Medical Device Manufacturer · US , Salt Lake City , UT

Bard Access Systems, Inc. - FDA 510(k) Cleared Devices

21 submissions · 20 cleared · Since 1993

Recent clearances: Vaccess™ CT Low-Profile Power-Injectable Implantable Port, PowerPort™ isp Implantable Port, PowerLoc™ Max Power Injectable Infusion Set

21

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bard Access Systems, Inc. General Hospital ✕

15 devices

1-12 of 15

Cleared Sep 05, 2025

Vaccess™ CT Low-Profile Power-Injectable Implantable Port

General Hospital · 29d

Cleared Jun 18, 2025

PowerPort™ isp Implantable Port

General Hospital · 56d

Cleared Nov 27, 2024

PowerLoc™ Max Power Injectable Infusion Set

General Hospital · 198d

Cleared Oct 31, 2024

PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim...

General Hospital · 86d

Cleared Aug 24, 2022

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

General Hospital · 30d

Cleared Jul 30, 2021

BD PowerPiCC Catheter

General Hospital · 179d

Cleared Jan 13, 2006

General Hospital · 28d

Cleared Nov 23, 2005

General Hospital · 153d

Cleared Apr 18, 2005

BARDPORT TITANIUM PORTS

General Hospital · 69d

Cleared Nov 07, 1997

GESCO PER-Q-CATH PICC CATHETERS

General Hospital · 182d

Cleared Nov 07, 1997

GESCO PER-Q-CATH MIDLINE CATHETERS

General Hospital · 182d

Cleared Feb 17, 1995

VASCULAR ACCESS CATHETER ACCESSORIES

General Hospital · 466d