Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Vascular-Vascular Solutions - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2008

Recent clearances: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM, MODIFICATION TO: FOX PLUS PTA CATHETER

6

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Vascular-Vascular Solutions Cardiovascular ✕

5 devices

1-5 of 5

Cleared May 22, 2009

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19

Cardiovascular · 70d

Cleared Mar 20, 2009

FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS...

Cardiovascular · 22d

Cleared Sep 11, 2008

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Cardiovascular · 101d

Cleared Mar 26, 2008

MODIFICATION TO: FOX PLUS PTA CATHETER

Cardiovascular · 54d

Cleared Jan 31, 2008

VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER

Cardiovascular · 122d