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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

K082412 is an FDA 510(k) premarket notification submitted by Mapquet Cardiopulmonary AG for the device "VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160". The FDA issued a decision of Substantially Equivalent on November 10, 2008. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230.

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

Other clearances for product code DTP

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  • K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED (April 26, 2001)
  • K002591 — COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (September 13, 2000)
  • K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (March 9, 1999)
  • K984322 — DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (March 2, 1999)
  • K962726 — BARD QUANTUM CVR (October 30, 1996)
  • 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)

FDA data resources