MEDICAL COMPONENTS INC

FDA Device Registration & Listing · HARLEYSVILLE, PA, US · Registration 2518902

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2518902
FEI Number
2518902
Entity Name
MEDICAL COMPONENTS INC
City/State/Country
HARLEYSVILLE, PA, US
Establishment Address
1499 DELP DRIVE, HARLEYSVILLE, PA 19438, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Medical Components Inc (Owner Number: 2518902)
Owner / Operator Contact Address
1499 Delp Drive, Harleysville, PA 19438, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K120981
PMA Number
N/A

All Registered Proprietary Names

Pro-PICC(R) CT Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes 20G X 3/4" Pro-Lock Safety Infusion Set Duralock

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2011-08-12
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2008-03-21
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-09-17
PND Midline Catheter General Hospital Class 2 880.5200 2018-08-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-06-13
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2008-03-21
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2012-09-17
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2016-11-17
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-03-10
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2019-01-14
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2008-03-21
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 1994-01-26
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-04-23
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2015-10-26
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 1992-11-17
MZY Graft, Vascular, Stainless Steel Tunneler Cardiovascular Class 2 870.3450 2016-08-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-08-09
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2019-08-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-08-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-10-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-07-18
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2008-03-21
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2017-06-08
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2018-08-17
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-11-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-07-18
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2021-09-17
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2017-05-01
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2006-07-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2012-09-25
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2014-01-23
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2013-12-13
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2015-01-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-02-12
KNZ Accessories, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2015-10-26
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-03-10
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2009-04-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2018-08-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-01-24
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2009-04-21
KNZ Accessories, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2011-01-03
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2017-12-04
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2013-06-13
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2025-08-13
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-08-08
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-09-04
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2008-03-21
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2014-03-10
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2011-08-12
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2017-03-02
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-07-09
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2018-08-09
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-03-10
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2008-03-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2008-03-21
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2008-03-21
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-04-12
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2016-03-24
HXD Clamp General, Plastic Surgery Class 1 878.4800 2016-11-17
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2011-12-27
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2015-01-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2009-04-21
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2009-04-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-02-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-12-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-11-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-01-21
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2011-11-30
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2013-05-20
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2011-08-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-08-09
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2009-04-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-08-15
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2018-08-09
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2018-08-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-07-18
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2016-04-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-11-30
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-08-02
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2013-12-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-08-22
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-08-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-04-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-04-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-06-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-07-15
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-05-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-08-12
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2018-08-08
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-02-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 1997-11-24
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2025-07-18
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2016-08-26
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-02-24
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-02-24
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2014-02-26
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2014-02-26
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2018-08-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2009-04-21
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-12-18
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2017-05-02
KNZ Accessories, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2018-08-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 1992-11-17
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2006-01-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-06-04
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2011-08-12
PND Midline Catheter General Hospital Class 2 880.5200 2017-07-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-12
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2023-11-20
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2014-02-14
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-05-17

Official Correspondent

Martina Arno

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medical Components Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013750125 Medical Components, Inc. Yuma, AZ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K971999 B.Braun Medical, Inc. PERIPHERALLY INSERTED CENTRAL 1997-11-24
K171618 Medcomp (Dba Medical Components, Inc.) Symetrex Long Term Hemodialysis Catheter 2017-11-16
K111817 Covidien PALINDROME RT CHRONIC CATHETER 2011-08-30
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0004-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015 Navilyst Medical, Inc 2
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518902. Last updated year: 2026. Please use registration number 2518902 when referencing this establishment in official correspondence.
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