DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
FDA 510(k) clearance K984322 · decided 1999-03-02
Clearance details
- K-number
- K984322
- Device name
- DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
- Applicant
- Dideco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-03
- Decision date
- 1999-03-02
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DTP
- Device class
- 2
- Regulation number
- 870.4230
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG (K101186) | Medtronic Perfusion Systems | 2010-09-03 |
| VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 (K082412) | Mapquet Cardiopulmonary AG | 2008-11-10 |
| COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K004046) | Cobe Cardiovascular, Inc. | 2001-04-26 |
| COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K002591) | Cobe Cardiovascular, Inc. | 2000-09-13 |
| MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (K990514) | C.R. Bard, Inc. | 1999-03-09 |
| BARD QUANTUM CVR (K962726) | C.R. Bard, Inc. | 1996-10-30 |
| SARNS FILTERED VENOUS RESERVIOR MODIFICATION (K941654) | 3M Health Care, Sarns | 1994-07-26 |
| MAXIMA FILTERED HARDSHELL RESERVIOR (K933496) | Medtronic Vascular | 1993-10-15 |
| SARNS NON-FILTERED VENOUS RESERVOIR (K912915) | 3M Health Care, Ltd. | 1991-09-25 |
| MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (K911789) | Medtronic Vascular | 1991-08-20 |
| MODEL 5866-46 SLEEVE KIT (K910568) | Medtronic Vascular | 1991-04-09 |
| COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (K902437) | Cobe Laboratories, Inc. | 1990-12-17 |
Recalls involving this device
No recalls on record reference this clearance.