Medical Device Manufacturer · US , Redwood City , CA

Fox Hollow Technologies - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2003

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fox Hollow Technologies Cardiovascular ✕

5 devices

1-5 of 5

Cleared Feb 12, 2008

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

Cardiovascular · 265d

Cleared Nov 09, 2007

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

Cardiovascular · 129d

Cleared Jan 13, 2006

MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,...

Cardiovascular · 31d

Cleared Feb 18, 2005

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200,...

Cardiovascular · 53d

Cleared Jun 20, 2003

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200

Cardiovascular · 179d