Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005704822

FEI Number

3005704822

Entity Name

pfm medical mepro gmbh

City/State/Country

Nonnweiler-Otzenhausen Saarland, DE

Establishment Address

Am Soterberg 4, Nonnweiler-Otzenhausen Saarland 66620, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PFM MEDICAL GMBH (Owner Number: 9035772)

Owner / Operator Contact Address

1916 Palomar Oaks Way, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P120009

All Registered Proprietary Names

Micro Introducer CTS 500 Cassette Trimming System Port MULTISNARE primePICC primePICC Port primePICC Nit-Occlud PDA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2025-04-14
IDT	Apparatus, Melting Point, Paraffin	Pathology	Class 1	864.3010	2018-01-17
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2026-05-28
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-11-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1999-12-21
OZH	Transcatheter Septal Occluder (Ventricular)	Unknown	Class 3	N/A	2016-07-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-04-14
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2016-07-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-04-14
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-11-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-04-14
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2013-09-04

Official Correspondent

Jessica Jho

US Agent Details

Jessica Jho Email: jjho@pfmmedicalusa.com Phone: (801) 4559267

Related Public Records

Same Entity

PFM MEDICAL GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617465	PFM Medical GmbH	COLOGNE North Rhine-Westphalia, DE

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
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K213494	ABBOTT MEDICAL	Aveir Retrieval Catheter	2022-04-01

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 3005704822. Last updated year: 2026. Please use registration number 3005704822 when referencing this establishment in official correspondence.