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510(k) K030398

CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 by Cardiacassist, Inc. — Product Code DQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2003
Date Received
February 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type

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  • K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULA (March 28, 1990)
  • K894243 — RMI ARTERIAL PERFUSION CANNULA (September 19, 1989)
  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K884478 — DAIG COLLAPSIBLE STERILE SLEEVE (February 22, 1989)
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