Atlas FDA

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE

FDA 510(k) clearance K121767 · decided 2012-07-13

Clearance details

K-number
K121767
Device name
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2012-06-15
Decision date
2012-07-13
Days to decision
28 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mounds View, 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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SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
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