Medical Device Manufacturer · US , West Valley City , UT

Boston Scientific - Precision Vascular - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2005

Recent clearances: PVS 2000 SYNCHRO2 GUIDEWIRE, PV 1900 SYNCHRO 0.016 GUIDEWIRE, PIVOT STEERABLE MICROCATHETER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boston Scientific - Precision Vascular Cardiovascular ✕

3 devices

1-3 of 3

Cleared Mar 13, 2006

PVS 2000 SYNCHRO2 GUIDEWIRE

Cardiovascular · 110d

Cleared Jun 13, 2005

PV 1900 SYNCHRO 0.016 GUIDEWIRE

Cardiovascular · 56d

Cleared Mar 22, 2005

PIVOT STEERABLE MICROCATHETER

Cardiovascular · 11d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 26, 2026