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510(k) K990514

MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR by C.R. Bard, Inc. — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1999
Date Received
February 18, 1999
Clearance Type
Special
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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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)
  • 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)