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510(k) K991170

RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 by Edwards Lifesciences Research Medical — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1999
Date Received
April 7, 1999
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 Edwards Lifesciences Research Medical

  • K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA (January 31, 2008)
  • K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LA (September 27, 2006)
  • K990396 — T-ANASTAFLO (October 1, 1999)
  • K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (June 11, 1999)
  • K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (December 1, 1998)

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