Atlas FDA

MAXIMA FILTERED HARDSHELL RESERVIOR

FDA 510(k) clearance K933496 · decided 1993-10-15

Clearance details

K-number
K933496
Device name
MAXIMA FILTERED HARDSHELL RESERVIOR
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1993-07-19
Decision date
1993-10-15
Days to decision
88 days
Clearance type
Traditional
Product code
DTP
Device class
2
Regulation number
870.4230
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Anaheim, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Vascular

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
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
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08