Medical Device Manufacturer · US , Salt Lake City , UT

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

7 submissions · 7 cleared · Since 1999

Recent clearances: PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER, PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES, PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Sep 05, 2003

PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

Cardiovascular · 23d

Cleared Aug 12, 2003

PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

Cardiovascular · 29d

Cleared Dec 04, 2002

PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE

Cardiovascular · 30d

Cleared Mar 21, 2002

Cardiovascular · 15d

Cleared Mar 08, 2001

PVS 1300 NEURO GUIDE WIRE

Cardiovascular · 171d

Cleared Nov 08, 2000

PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING

Cardiovascular · 70d

Cleared Jul 23, 1999

PVS 1400 GUIDEWIRE

Cardiovascular · 133d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 10, 2026