Cleared Traditional

DIDECO D920, LILLIPUT 1 TWIN RESERVOIR

K984322 · Dideco S.P.A. · Cardiovascular
Mar 1999
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K984322 is an FDA 510(k) clearance for the DIDECO D920, LILLIPUT 1 TWIN RESERVOIR, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on March 2, 1999, 89 days after receiving the submission on December 3, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K984322 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1998
Decision Date March 02, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTP — Defoamer, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4230

Similar Devices — DTP Defoamer, Cardiopulmonary Bypass

All 33
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · Medtronic Perfusion Systems · Sep 2010
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
K082412 · Mapquet Cardiopulmonary AG · Nov 2008
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc. · Apr 2001
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc. · Sep 2000
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996

More from Dideco S.P.A.

View all
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · DTM · May 2004
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
K033323 · DTZ · Jan 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · DTM · Jan 2004
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K033714 · DTN · Dec 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K032040 · KFM · Jul 2003