510(k) K082782

REPLICATION MEDICAL VESSEL GUARD by Replication Medical, Inc. — Product Code OMR

Clearance Details

Decision: SESU ()
Decision Date: April 2, 2009
Date Received: September 22, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Vessel Guard Or Cover
Device Class: Class II
Regulation Number: 870.3470
Review Panel: CV
Submission Type

These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.

Other clearances for product code OMR

K111048 — SYNTHES SCOUT TACK FIXATION (June 14, 2012)
K111137 — HYDROFIX VASO SHIELD (May 20, 2011)
K101805 — HYDROFIX VASO SHIELD (April 8, 2011)
K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (July 28, 2010)
K100984 — XYLOS VESSEL GUARD (July 7, 2010)
K100905 — HYDROFIX SURGICAL SHEET (June 2, 2010)
K093551 — PARADIS VASO SHIELD (December 24, 2009)
K090022 — PARADIS VASO SHIELD (April 20, 2009)