PFM Medical, Inc

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3013666218

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
3013666218
FEI Number
3013666218
Entity Name
PFM Medical, Inc
City/State/Country
Carlsbad, CA, US
Establishment Address
1916 Palomar Oaks Way, Suite 150, Carlsbad, CA 92008, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
PFM MEDICAL, INC (Owner Number: 9052164)
Owner / Operator Contact Address
1916 Palomar Oaks Way, Suite 150, Carlsbad, CA 92008, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

JET PORT PLUS CATHETER SYSTEM T-Port HP Infusion Port PFM Various Microtome Accessories Tita Jet Light HP Catheter System Jet Port Plus HP Catheter System primeMidline PFM PICC primePICC MULTI-SNARE SET Jet-Vac Asept ASEPT Asept PFM Sliding Microtome Stylet Asept Veta Peritoneal Dialysis Insertion Kit Asept Drainage Bag PFM Water Bath Jet-Vac Rapid Centesis Catheter pfm Microintroducer Kit Asept Peritoneal Drainage System T-Port HP Catheter System REDON SET

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 2002-07-18
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2008-01-04
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2020-08-28
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-07-27
IDL Microtome, Accessories Pathology Class 1 864.3010 2011-01-08
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2008-03-17
PND Midline Catheter General Hospital Class 2 880.5200 2018-03-19
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2008-01-04
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2002-07-18
MAE Occluder, Patent Ductus, Arteriosus Unknown Class 3 N/A 2014-01-02
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2013-05-10
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2023-05-23
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2013-07-22
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2020-02-21
KFL Microtome, Sliding Pathology Class 1 864.3010 2011-01-08
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-09-21
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2018-01-23
PPJ Peritoneal Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5630 2017-12-14
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2012-06-18
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2011-01-08
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2021-07-27
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2011-06-03
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2009-11-17
OFC Catheter Introducer Kit Cardiovascular Class 2 870.1340 2017-01-26
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2010-03-24
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2008-01-04
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2002-07-18
IDO Microtome, Rotary Pathology Class 1 864.3010 2011-01-08

Official Correspondent

Jiaye Jho

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PFM MEDICAL, INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013666218. Last updated year: 2026. Please use registration number 3013666218 when referencing this establishment in official correspondence.
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