Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013750125

FEI Number

3013750125

Entity Name

Medical Components, Inc.

City/State/Country

Yuma, AZ, US

Establishment Address

3088 East 33rd Place, Yuma, AZ 85365, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medical Components Inc (Owner Number: 2518902)

Owner / Operator Contact Address

1499 Delp Drive, Harleysville, PA 19438, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K770977

PMA Number

N/A

All Registered Proprietary Names

Pro-PICC(R) CT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-04-22
MSD	Catheter, Hemodialysis, Implanted	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	2011-08-12
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-03-21
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-07-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-03-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-07-18

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
2518902	MEDICAL COMPONENTS INC	HARLEYSVILLE, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19
K893460	Therex Corp.	A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM	1989-06-23
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30

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 3013750125. Last updated year: 2026. Please use registration number 3013750125 when referencing this establishment in official correspondence.