Medical Device Manufacturer · US , Salt Lake City , UT

Bard Access Systems, Inc.

21 submissions · 20 cleared · Since 1993
21
Total
20
Cleared
0
Denied

Bard Access Systems, Inc. — FDA 510(k) Submissions

Bard Access Systems, Inc. has submitted 21 FDA 510(k) premarket notifications since 1993, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Port & Catheter, Implanted, Subcutaneous, Intravascular, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, System, Imaging, Pulsed Echo, Ultrasonic, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, System, Imaging, Pulsed Doppler, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
Vaccess? CT Low-Profile Power-Injectable Implantable Port; Vaccess? CT Power-Injectable Implantable Port; PowerPort? duo M.R.I. ? Implantable Port
K252478 · LJT Port & Catheter,... · General Hospital
Sep 2025 29d
PowerPort? isp Implantable Port; PowerPort? Slim Implantable Port; PowerPort? M.R.I. ? Implantable Port; PowerPort? M.R.I.? isp Implantable Port
K251253 · LJT Port & Catheter,... · General Hospital
Jun 2025 56d
PowerLoc? Max Power Injectable Infusion Set; SafeStep? Huber Needle Set
K241353 · PTI Non-coring (huber) Needle · General Hospital
Nov 2024 198d
PowerPort? ClearVUE? Slim Implantable Ports and PowerPort? ClearVUE? Slim Implantable Ports
K242328 · LJT Port & Catheter,... · General Hospital
Oct 2024 86d
BD Prevue? II Peripheral Vascular Access System
K240146 · IYO System, Imaging, Pulsed... · Radiology
Feb 2024 30d
Sherlock 3CG? Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232 · LJS Catheter, Intravascular,... · General Hospital
Aug 2022 30d
BD PowerPiCC Catheter
K210264 · LJS Catheter, Intravascular,... · General Hospital
Jul 2021 179d
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
K120882 · IYO System, Imaging, Pulsed... · Radiology
May 2012 68d
SITE-RITE VISION ULTRASOUND SYSTEM
K100402 · IYN System, Imaging, Pulsed... · Radiology
Mar 2010 17d
ASPIRA PLEURAL DRAINAGE SYSTEM
K071095 · DWM Apparatus, Suction,... · Anesthesiology
May 2007 30d
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
K053589 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Apr 2006 111d
POWERPICC
K053501 · LJS Catheter, Intravascular,... · General Hospital
Jan 2006 28d
POWERPICC
K051672 · LJS Catheter, Intravascular,... · General Hospital
Nov 2005 153d
BARDPORT TITANIUM PORTS
K050310 · LJT Port & Catheter,... · General Hospital
Apr 2005 69d
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
K042445 · ITX Transducer, Ultrasonic,... · Radiology
Oct 2004 40d
GESCO PER-Q-CATH PICC CATHETERS
K971990 · FOZ Catheter, Intravascular,... · General Hospital
Nov 1997 182d
GESCO PER-Q-CATH MIDLINE CATHETERS
K971991 · FOZ Catheter, Intravascular,... · General Hospital
Nov 1997 182d
VASCULAR ACCESS CATHETER ACCESSORIES
K935380 · LJS Catheter, Intravascular,... · General Hospital
Feb 1995 466d
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
K926139 · LJT Port & Catheter,... · General Hospital
Jan 1995 757d
3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
K926331 · LJS Catheter, Intravascular,... · General Hospital
Mar 1994 446d
PLASTIC LOW PROFILE SUBCUTANEOUS PORT
K924250 · LJT Port & Catheter,... · General Hospital
Oct 1993 406d
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