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510(k) K813037

FLOWGUARD CATHETERS & CANNALAE by Advocacy International, Ltd. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1981
Date Received
October 28, 1981
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

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  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)

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