Atlas FDA

CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

FDA 510(k) clearance K013392 · decided 2002-01-25

Clearance details

K-number
K013392
Device name
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2001-10-15
Decision date
2002-01-25
Days to decision
102 days
Clearance type
Abbreviated
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Shoreview, MN, 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

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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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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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