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510(k) K031903

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 by Guidant Corporation — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2004
Date Received
June 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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  • K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)

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