Medical Device Manufacturer · US , Redwood , CA

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

20 submissions · 17 cleared · Since 2000

20

Total

17

Cleared

0

Denied

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

14 devices

1-12 of 14

Cleared Dec 19, 2014

Hi-Torque JET Guide Wire Family

Cardiovascular · 113d

Cleared Jan 29, 2013

PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY

Cardiovascular · 120d

Cleared Nov 20, 2012

HI-TORQUE COMMAND GUIDE WIRE FAMILY

Cardiovascular · 89d

Cleared Dec 07, 2010

ARMADA 14 PTA CATHETER

Cardiovascular · 78d

Cleared Jul 08, 2010

HI-TORQUE WINN GUIDE WIRE FAMILY

Cardiovascular · 27d

Cleared May 24, 2010

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

Cardiovascular · 42d

Cleared Sep 25, 2009

HI-TORQUE PROGRESS GUIDE WIRE FAMILY

Cardiovascular · 98d

Cleared Jun 04, 2008

FOXCROSS PTA CATHETER

Cardiovascular · 15d

Cleared Apr 28, 2008

FOX PLUS PTA CATHETER

Cardiovascular · 26d

Cleared Apr 11, 2008

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Cardiovascular · 224d

Cleared Feb 06, 2007

STARCLOSE HEX-HUB DILATOR

Cardiovascular · 160d

Cleared Jul 07, 2006

STARCLOSE INTRODUCER SET MODEL- 1002

Cardiovascular · 95d