Atlas FDA

BARD QUANTUM CVR

FDA 510(k) clearance K962726 · decided 1996-10-30

Clearance details

K-number
K962726
Device name
BARD QUANTUM CVR
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1996-07-15
Decision date
1996-10-30
Days to decision
107 days
Clearance type
Traditional
Product code
DTP
Device class
2
Regulation number
870.4230
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Haverhill, 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.

RecordFirmDate
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG (K101186)Medtronic Perfusion Systems2010-09-03
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 (K082412)Mapquet Cardiopulmonary AG2008-11-10
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
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (K984322)Dideco S.P.A.1999-03-02
SARNS FILTERED VENOUS RESERVIOR MODIFICATION (K941654)3M Health Care, Sarns1994-07-26
MAXIMA FILTERED HARDSHELL RESERVIOR (K933496)Medtronic Vascular1993-10-15
SARNS NON-FILTERED VENOUS RESERVOIR (K912915)3M Health Care, Ltd.1991-09-25
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (K911789)Medtronic Vascular1991-08-20
MODEL 5866-46 SLEEVE KIT (K910568)Medtronic Vascular1991-04-09
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.

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01