Medical Device Manufacturer · US , Redwood , CA

Abbott Vascular, Inc. - FDA 510(k) Cleared Devices

20 submissions · 17 cleared · Since 2000

Recent clearances: Hi-Torque JET Guide Wire Family, PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY, HI-TORQUE COMMAND GUIDE WIRE FAMILY

Total

Cleared

Denied

Abbott Vascular, Inc. has 17 FDA 510(k) cleared cardiovascular devices. Based in Redwood, US.

Historical record: 17 cleared submissions from 2000 to 2014.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

Abbott Vascular, Inc. is one of 12980 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Abbott Vascular, Inc.

20 devices

1-20 of 20

Cleared Dec 19, 2014

Hi-Torque JET Guide Wire Family

K142415 · DQX

Cardiovascular · 113d

Cleared CT Jan 29, 2013

PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY

K123067 · DQX

Cardiovascular · 120d

Cleared Nov 20, 2012

HI-TORQUE COMMAND GUIDE WIRE FAMILY

K122573 · DQX

Cardiovascular · 89d

Cleared Dec 07, 2010

ARMADA 14 PTA CATHETER

K102705 · LIT

Cardiovascular · 78d

Cleared Jul 08, 2010

HI-TORQUE WINN GUIDE WIRE FAMILY

K101648 · DQX

Cardiovascular · 27d

Cleared May 24, 2010

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

K101011 · DQX

Cardiovascular · 42d

Cleared Sep 25, 2009

HI-TORQUE PROGRESS GUIDE WIRE FAMILY

K091825 · DQX

Cardiovascular · 98d

Cleared Jun 04, 2008

FOXCROSS PTA CATHETER

K081417 · LIT

Cardiovascular · 15d

Cleared Apr 28, 2008

FOX PLUS PTA CATHETER

K080925 · LIT

Cardiovascular · 26d

Cleared Apr 11, 2008

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

K072460 · DQX

Cardiovascular · 224d

Cleared Sep 14, 2007

MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM

K063481 · FGE

Gastroenterology & Urology · 301d

Cleared Feb 06, 2007

STARCLOSE HEX-HUB DILATOR

K062554 · DRE

Cardiovascular · 160d

Cleared Jul 07, 2006

STARCLOSE INTRODUCER SET MODEL- 1002

K060902 · DYB

Cardiovascular · 95d

Cleared Oct 22, 2003

MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT...

K032929 · FGE

Gastroenterology & Urology · 30d

Cleared Aug 12, 2003

WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM

K031331 · FGE

Gastroenterology & Urology · 106d

Cleared Aug 23, 2002

CHITO-SEAL

K021062 · QSY

General & Plastic Surgery · 143d

Cleared Jan 11, 2002

MODIFICATION TO SUPERCROSS CATHETER

K014118 · DQY

Cardiovascular · 28d

Cleared Dec 06, 2001

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

K013683 · GAW

General & Plastic Surgery · 29d

Cleared Mar 07, 2001

SUPERCROSS CATHETER

K001856 · DQY

Cardiovascular · 261d

Cleared Oct 03, 2000

PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

K001703 · GAW

General & Plastic Surgery · 120d

Abbott Vascular, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Abbott Vascular, Inc.

Filters