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510(k) K100905

HYDROFIX SURGICAL SHEET by Mimedx Group, Inc. — Product Code OMR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2010
Date Received
April 1, 2010
Clearance Type
Special
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 by Mimedx Group, Inc.

  • K100313 — HYDROFIX SURGICAL SHEET (June 14, 2011)
  • K111137 — HYDROFIX VASO SHIELD (May 20, 2011)
  • K101805 — HYDROFIX VASO SHIELD (April 8, 2011)
  • K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (July 28, 2010)

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)
  • K093551 — PARADIS VASO SHIELD (December 24, 2009)
  • K090022 — PARADIS VASO SHIELD (April 20, 2009)
  • K082782 — REPLICATION MEDICAL VESSEL GUARD (April 2, 2009)