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510(k) K082412

VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 by Mapquet Cardiopulmonary AG — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2008
Date Received
August 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type

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  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K933496 — MAXIMA FILTERED HARDSHELL RESERVIOR (October 15, 1993)
  • K912915 — SARNS NON-FILTERED VENOUS RESERVOIR (September 25, 1991)
  • K911789 — MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (August 20, 1991)