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510(k) K984322

DIDECO D920, LILLIPUT 1 TWIN RESERVOIR by Dideco S.P.A. — Product Code DTP

K984322 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "DIDECO D920, LILLIPUT 1 TWIN RESERVOIR". The FDA issued a decision of Substantially Equivalent on March 2, 1999. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. Dideco S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1999
Date Received
December 3, 1998
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 by Dideco S.P.A.

  • K052717 — D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (October 20, 2005)
  • K051232 — D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDI (May 20, 2005)
  • K050890 — ECC.O SYSTEM (May 5, 2005)
  • K050447 — PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (March 8, 2005)
  • K043323 — D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE (February 1, 2005)
  • K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (May 6, 2004)
  • K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HO (January 13, 2004)
  • K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (January 8, 2004)
  • K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COAT (December 11, 2003)
  • K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, (July 9, 2003)

Other clearances for product code DTP

  • K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDI (September 3, 2010)
  • K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODE (November 10, 2008)
  • 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)
  • 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