Atlas FDA

CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM

FDA 510(k) clearance K031247 · decided 2003-07-17

Clearance details

K-number
K031247
Device name
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2003-04-18
Decision date
2003-07-17
Days to decision
90 days
Clearance type
Traditional
Product code
GEI
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 (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