Medical Device Manufacturer · US , Mountain View , CA

Hotspur Technologies, Inc., - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2014

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hotspur Technologies, Inc., Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 24, 2015

0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)

Cardiovascular · 239d

Cleared Sep 17, 2014

Arrow GPSCath Balloon Dialation Catheter (150 cm)

Cardiovascular · 30d