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510(k) K864101

COOK (R) VEIN GRAFT RING MARKERS by Cook, Inc. — Product Code KPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
October 21, 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

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  • K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (October 9, 2014)
  • K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUT (April 18, 2014)
  • K131772 — CANTATA(R) 2.9 MICROCATHETER (February 20, 2014)
  • K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER (January 29, 2014)
  • K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (December 23, 2013)
  • K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (October 25, 2013)
  • K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GAST (October 7, 2013)
  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)

Other clearances for product code KPK

  • K971966 — CORONARY VEIN GRAFT TAG MARKER (January 26, 1998)
  • K895369 — VOSS GRAFT MARKER (September 27, 1989)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K801637 — FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (August 27, 1980)
  • K770802 — MARKERS, STAINLESS STEEL (June 27, 1977)