Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003915875

FEI Number

3003915875

Entity Name

MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.

City/State/Country

MEXICALI Baja California, MX

Establishment Address

CALLE MERCURIO N 46, PARQUE INDUSTRIAL MEXICALI 1, MEXICALI Baja California C.P. 21210, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MARTECH MEDICAL PRODUCTS (Owner Number: 2527072)

Owner / Operator Contact Address

1500 Delp Drive, --, Harleysville, PA 19438, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PTFE TERAWAY SHORT TERM HEMODIALYSIS CATHETER HEMO-FLOW DOUBLE LUMEN CATHETER DUO-SPLIT DOUBLE LUMEN CATHETERS LONG TERM HEMODIALYSIS CATHETER CATHTONG II PICC Catheter DOUBLE LUMEN CATHETER Gen III Power Injectable Port ASPIRE ASSIST A-TUBE HEMODIALYSIS CATHETER NON-ABSORBABLE SUTURE SPLIT STREAM PRO-PICC NERVE BLOCK CATHETER VESSEL DILATOR INTRODUCER SET LOCKING NEEDLE AND TEARAWAY SHEATH ASSEMBLY PORT ASSEMBLY VENOUS / ARTERIAL HEMO-CATHETER KIT INTRODUCER SET CURVED GENERIC CATHETER SINGLE LUMEN Arch-Flo CT MIDLINE INTRAKIT NEEDLE CATHTONG II PICC Catheter DRAINAGE CATHETER LONG TERM HEMODIALYSIS CATHETER DOUBLE LUMEN SUBCLAVIAN FEMORAL SIDE BY SIDE CATHETERS SINGLE LUMEN STRAIGHT CATHETER SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT SPLIT CATH II (III) (CHRONOFLEX) (TRANSLUMBAR) TUNNELER PRO-LOCK CT SAFETY INFUSION 1.9F VASCU-PICC® (PEDIATRICS) (DUROMETER 2363-80A) Eschelon SOFT-LINE IJ & RAULERSON/DUO-FLOW IJ DOUBLE LUMEN CATH(11.5F X12,15, 20CM) FEMORAL CATHETER LUMEN CT PICC DUAL JET POWER INJECTABLE Kimberly Clark Introducer Kits X SIDE DOUBLE LUMEN CATHETER FREE FLOW LONG-TERM COAXIAL CATHETER "X" SERIES PD CATHETER PRO-PICC WITH VALVE TECHNOLOGY SINGLE LUMEN CT MIDLINE PERITONEAL CATHETER Medcomp Power Injectable Safety Huber Needle BIO FLEX, TESIO NASAL CL SPLINT SEPTAL GUIDWIRE LONG TERM INFUSION CATHETER SUBCLAVIAN CATHETER SAFETY NEEDLE AC1162MB-6 AC1045MB-6 Vascu Sheath INTRODUCER CATHETER AC1041MB-6 POLYPROPYLENE DILATOR Pro-Line CATHETER STYLET BIO-CATH CENTRAL VENOUS ACCESS CATHETER SILICONE HEMO-CATH STRAIGHT FEMORAL CATHETER Surgitek Double-J Ureteral Stent OTN FOR PICC CT PORT W/SILICONE FILLED SUTURE HOLES TERAWAY INTRODUCER SET DUCKBILL VALVE ACMI Y-Connector, Luer Lock; Biopsy Port Seal, AUR-BP and UBP-Y Jet Power Injectable PICC DIGNITY® POWER INJECTABLE TITANIUM PORT SINGLE LUMEN VASCU-PICC Surgitek Urinary Diversion Stent NITINOL GUIDEWIRE ESOPHAGEAL STETHOSCOPE URETERAL STENT NEEDLE SHEATH SPLIT CATH RG Circon-Surgitek Classic Double Pigtail Ureteral Stent 10F PEDIATRIC ASH-SPLIT CATH XL MID-SIZED CT PORT Pro-Line 2.6F VASCU-PICC (DUROMETER 2363-80A) Dual Lumen Catheter SKIN PROTECTANT SWABSTICKS FEMORAL CATHETER WITH "Y" HUB VESSEL DILATOR Percutaneous Cathether Introducer with Touhy Borst Adaptor Allevio INTRODUCER NEEDLE TESIO CATHETERS NON CORING HUBER NEEDLE DIGNITY DUAL PORT CT MIDLINE CATHETER Medcomp Flexi-Smooth W STRAIGHT CATHETER SET ProGuide Long Term Hemodialysis Catheters PRO-PICC® CT (6F X 60CM TRIPLE) biopsy port seal GAUZE SPONGE DOUBLE LUMEN CATHETER SINGLE LUMEN TAPERLESS VASCU-PICC Triple Lumen Infusion Catheter (Multi-Cath) TRI-FLOW TRIPLE LUMEN CATHETER BAXTER HEMOSTASIS VALVE INTRODUCERS 18 X 45 GW KIT FEMORAL CATHETER Quad Lumen Multi-Cath Minop Disposable Introducer Multi Cath Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-02
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-20
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-25
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-12-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-04-16
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-11-24
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-01-22
OYF	Aspiration Therapy System	Unknown	Class 3	N/A	2017-03-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-10-15
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2017-01-06
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2016-05-20
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-20
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-11-15
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2014-04-04
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2017-07-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-03-17
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2018-01-03
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2017-07-31
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2016-11-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-11-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2017-03-01
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2019-07-31
PND	Midline Catheter	General Hospital	Class 2	880.5200	2019-07-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-04-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-04-16
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-10-26
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
KNZ	Accessories, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2016-06-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-25
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2019-08-01
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2014-01-23
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-20
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2018-05-08
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2019-02-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-05-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-25
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-04-12
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
LFK	Catheter, Femoral	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2019-04-18
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-09-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-25
PND	Midline Catheter	General Hospital	Class 2	880.5200	2018-10-18
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2014-06-18
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-04-30
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-05-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-06-17
PND	Midline Catheter	General Hospital	Class 2	880.5200	2020-01-23
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2006-05-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-01-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2020-11-26
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2017-03-27
DOX	Fluorometer, Lead (Dedicated Instruments)	Clinical Toxicology	Class 2	862.3550	2006-05-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2020-11-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2006-05-18
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2006-05-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2015-01-13
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2016-11-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-05-23
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-07-23
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-09-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-11-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-09-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-07-07
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2017-07-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-27
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-03-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2023-05-19
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-08-13
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-06-09
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2020-03-10
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-09-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-07-31
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2006-05-18
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-01-04
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2018-11-08
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-06-30
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-09-12
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2020-07-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2015-01-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-06-17
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2013-09-12
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-02-12
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-07-25
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2006-05-18
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	Class 1	874.4175	2015-06-15
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2018-07-06
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-05-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-08-05
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2017-07-26
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-06-17
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-05-23
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2016-01-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-07-25
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-06-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-06-17
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-03-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-12-14
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2019-02-25
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2019-07-10
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2016-01-22
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2019-08-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-01-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-04-07
LFK	Catheter, Femoral	Gastroenterology, Urology	Class 2	876.5540	2018-07-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-04-12
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2016-01-22
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

Daryl Clark Business: MARTECH MEDICAL PRODUCTS Email: regulatory@martechmedical.com Phone: (215) 2568833

Related Public Records

Same Entity

MARTECH MEDICAL PRODUCTS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2527072	MARTECH MEDICAL PRODUCTS	HARLEYSVILLE, PA, US

Related 510(k) Records

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K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

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Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003915875. Last updated year: 2026. Please use registration number 3003915875 when referencing this establishment in official correspondence.