FDA 510(k), K142461, VASCU-GUARD Peripheral Vascular Patch

510(K) Number: K142461
Device Name: VASCU-GUARD Peripheral Vascular Patch
Manufacturer: Synovis Life Technologies Inc.
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 09/02/2014
Decision Date: 11/25/2014
Regulation Medical Specialty: Cardiovascular

155 pages (1,407 of 1,557 original pages are fully redacted.