Atlas FDA

COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

FDA 510(k) clearance K902437 · decided 1990-12-17

Clearance details

K-number
K902437
Device name
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
Applicant
Cobe Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1990-06-04
Decision date
1990-12-17
Days to decision
196 days
Clearance type
Traditional
Product code
DTP
Device class
2
Regulation number
870.4230
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Arvada, CO, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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.