Home / 510(k) Clearances / K801637

510(k) K801637

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. by C.R. Bard, Inc. — Product Code KPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
July 17, 1980
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 C.R. Bard, Inc.

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)
  • K213203 — Provena(TM) Midline Catheter (May 13, 2022)
  • K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PT (May 4, 2022)
  • K212708 — Halo One Thin-Walled Guiding Sheath (September 23, 2021)

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)
  • K864101 — COOK (R) VEIN GRAFT RING MARKERS (October 30, 1986)
  • K770802 — MARKERS, STAINLESS STEEL (June 27, 1977)