Home / 510(k) Clearances / K864919

510(k) K864919

SCANLAN (TM) VEIN/GRAFT HOLDER by Scanlan Intl., Inc. — Product Code KPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 16, 1986
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 Scanlan Intl., Inc.

  • K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (April 26, 1996)
  • K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER (December 5, 1994)
  • K911184 — SCANLAN/TAHERI VALVULOTOME (February 18, 1992)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K851825 — SCANLAN TUNNELER, SHEATH & TIP (July 12, 1985)
  • K841521 — SCANLAN ENDARSECTOR (August 3, 1984)
  • K841513 — SCANLAN ATRAUM INSTRUMENT JAW COVER (July 6, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)

Other clearances for product code KPK

  • K971966 — CORONARY VEIN GRAFT TAG MARKER (January 26, 1998)
  • K895369 — VOSS GRAFT MARKER (September 27, 1989)
  • 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)