Pfm Medical, Inc.
Pfm Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2025, with 10 FDA device recalls on record.
Top product codes for Pfm Medical, Inc.
FDA recalls by Pfm Medical, Inc.
- Z-2526-2026 — Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
- Z-0562-2015 — ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
- Z-0568-2015 — ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
- Z-0563-2015 — Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.
- Z-0564-2015 — 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
- Z-0560-2015 — Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
- Z-0565-2015 — ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
- Z-0566-2015 — Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
- Z-0567-2015 — Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
- Z-0561-2015 — ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Pfm Medical, Inc.
- K242763 — JetCan® Pro Safety Huber Needle
- K241278 — ASEPT® Glide Peritoneal Drainage System
- K221779 — ASEPT Peritoneal Drainage System
- K213666 — NuCath Wedge Pressure Catheter
- K201137 — Asept Surgical Face Mask
- K192802 — primeMidline Catheters
- K173114 — primeMidline Catheters
- K140137 — SAFETY BIOPSY NEEDLE SYSTEM
- K122402 — LPP (LOW PROFILE PORT)
- K113354 — VETA PERITONEAL DIALYSIS CATHETER
- K110914 — TRIPLE LUMEN PFM PICC
- K093796 — ASEPT PERITONEAL DRAINAGE SYSTEM
- K093307 — ASEPT PLEURAL DRAINAGE SYSTEM
- K083873 — PICC (CT RATED AND NON-RATED)
- K072481 — JET PORT PLUS HP CATHETER SYSTEM
- K073210 — MODIFICATION TO: T-PORT HP INFUSION PORT
- K072391 — PFM PICC
- K071993 — T-PORT HP INFUSION PORT
- K071846 — MODIFICATION TO EZ HUBER SAFETY INFUSION SET
- K040533 — EZ HUBER SAFETY INFUSION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.