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510(k) K052570

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 by Cardiacassist, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2006
Date Received
September 19, 2005
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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