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510(k) K990396

T-ANASTAFLO by Edwards Lifesciences Research Medical — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1999
Date Received
February 9, 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

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  • K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LA (September 27, 2006)
  • K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (July 2, 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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