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510(k) K082782

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

K082782 is an FDA 510(k) premarket notification submitted by Replication Medical, Inc. for the device "REPLICATION MEDICAL VESSEL GUARD". The FDA issued a decision of SESU on April 2, 2009. The device falls under product code OMR (Vessel Guard Or Cover), a Class II device regulated under 21 CFR 870.3470.

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)

FDA data resources