Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2527072

FEI Number

2527072

Entity Name

MARTECH MEDICAL PRODUCTS

City/State/Country

HARLEYSVILLE, PA, US

Establishment Address

1500 DELP DR., HARLEYSVILLE, PA 19438, US

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

FEMORAL CATHETER SHORT TERM INFUSION CATHETER SUBCLAVIAN CATHETER Kimberly Clark Introducer Kits INTRODUCER NEEDLE GUIDEWIRE PLACEMENT NEEDLES ProGuide Long Term Hemodialysis Catheters SHORT TERM HEMODIALYSIS CATHETER VALVED TEARAWAY INTRODUCER URETERAL STENT 18 Ga. Introducer Needle Catheter and Accessories VESSEL DILATOR Percutaneous Cathether Introducer with Touhy Borst Adaptor PERITONEAL CATHETER AC1162MB-6 AC1045MB-6 Vascu Sheath INTRODUCER CATHETER AC1041MB-6 POLYPROPYLENE DILATOR ESOPHAGEAL STETHOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFK	Catheter, Femoral	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2006-05-18
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2014-06-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-05-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-06-11
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2006-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-07-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-01-04
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-22
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2006-05-18
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2006-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2006-05-18
BZT	Stethoscope, Esophageal, With Electrical Conductors	Anesthesiology	Class 2	868.1920	2006-05-18

Official Correspondent

Daryl Clark

US Agent Details

No US Agent registered (Local establishment).

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
3003915875	MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.	MEXICALI Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
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.

Similar Registrations

Registration Number	Establishment Name	Location
2030624	Isomedix Operations, Inc.	Temecula, CA, US
3005987240	ALLWIN MEDICAL DEVICES, INC.	ANAHEIM, CA, US
1722746	MEDRON, LLC	SALT LAKE CITY, UT, US
3003915875	MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.	MEXICALI Baja California, MX
2518902	MEDICAL COMPONENTS INC	HARLEYSVILLE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2527072. Last updated year: 2026. Please use registration number 2527072 when referencing this establishment in official correspondence.