Atlas FDA

TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE

FDA 510(k) clearance K012538 · decided 2001-08-23

Clearance details

K-number
K012538
Device name
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2001-08-07
Decision date
2001-08-23
Days to decision
16 days
Clearance type
Special
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Ter recall (Z-1023-2016)Medtronic Perfusion Systems2016-02-26
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U recall (Z-2736-2015)Medtronic Perfusion Systems2015-09-04
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leach recall (Z-2106-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-08-27
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact recall (Z-0618-2013)Medtronic Inc. Cardiac Rhythm Disease Management2012-12-28

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
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S093)Medtronic Vascular2026-05-29
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