Atlas FDA

MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG

FDA 510(k) clearance K911790 · decided 1991-08-12

Clearance details

K-number
K911790
Device name
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1991-04-22
Decision date
1991-08-12
Days to decision
112 days
Clearance type
Traditional
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Anaheim, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S094)Medtronic Vascular2026-06-05
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Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S092)Medtronic Vascular2026-05-13
Endurant™ II/IIs Stent Graft System (P100021/S132)Medtronic Vascular2026-05-12
Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S090)Medtronic Vascular2026-03-25
Endurant™, Endurant™ II/lls Stent Graft System (P100021/S134)Medtronic Vascular2026-02-27
Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (P100040/S074)Medtronic Vascular2026-02-27
Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (P100021/S133)Medtronic Vascular2026-01-27