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510(k) K860743

CAROTID BYPASS SHUNT WITH SAMPLING ARM by Clincal Instruments Corp. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1986
Date Received
February 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Clincal Instruments Corp.

  • K902327 — EMBOLECTOMY CATHETER (February 25, 1991)
  • K860742 — CAROTID BYPASS SHUNT (May 28, 1986)
  • K852704 — TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT (November 26, 1985)
  • K844918 — OCCLUSION & OCCLUSION-IRRIGATION (August 5, 1985)
  • K821220 — MULTILUMEN INTRAVENOUS INFUSION CATHETER (July 9, 1982)
  • K790034 — INTRODUCERS (February 1, 1979)
  • K771043 — SWAN GANZ (December 20, 1977)

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