Atlas FDA

CARDF

FDA 510(k) clearance K823731 · decided 1983-01-05

Clearance details

K-number
K823731
Device name
CARDF
Applicant
Shiley, Inc.
Decision
Substantially Equivalent
Date received
1982-12-10
Decision date
1983-01-05
Days to decision
26 days
Clearance type
Traditional
Product code
DTP
Device class
2
Regulation number
870.4230
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Shiley

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
BARD QUANTUM CVR (K962726)C.R. Bard, Inc.1996-10-30
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S014)Shiley, Inc.1985-04-09
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
BJORK-SHILEY CARDIAC VALVE (P780008/S007)Shiley, Inc.1983-05-20
BJORK-SHILEY CARDIAC VALVE (P780008/S005)Shiley, Inc.1982-02-05