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510(k) K090022

PARADIS VASO SHIELD by Spinemedica, LLC — Product Code OMR

Clearance Details

Decision
SESU ()
Decision Date
April 20, 2009
Date Received
January 5, 2009
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 by Spinemedica, LLC

  • K093551 — PARADIS VASO SHIELD (December 24, 2009)

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)
  • K082782 — REPLICATION MEDICAL VESSEL GUARD (April 2, 2009)