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510(k) K971966

CORONARY VEIN GRAFT TAG MARKER by Med-Edge, Inc. — Product Code KPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1998
Date Received
May 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Ostia, Aorto-Saphenous Vein
Device Class
Class II
Regulation Number
878.4650
Review Panel
CV
Submission Type

Other clearances by Med-Edge, Inc.

  • K882314 — CORONARY VEIN GRAFT MARKER (August 4, 1988)

Other clearances for product code KPK

  • K895369 — VOSS GRAFT MARKER (September 27, 1989)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K864101 — COOK (R) VEIN GRAFT RING MARKERS (October 30, 1986)
  • K801637 — FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (August 27, 1980)
  • K770802 — MARKERS, STAINLESS STEEL (June 27, 1977)