Atlas FDA

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

FDA 510(k) clearance K091582 · decided 2009-12-04

Clearance details

K-number
K091582
Device name
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2009-06-02
Decision date
2009-12-04
Days to decision
185 days
Clearance type
Traditional
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV3 recall (Z-0264-2014)Medtronic Vascular2013-11-15

PMA approvals by this applicant

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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
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