Atlas FDA

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205

FDA 510(k) clearance K090721 · decided 2009-06-16

Clearance details

K-number
K090721
Device name
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2009-03-18
Decision date
2009-06-16
Days to decision
90 days
Clearance type
Traditional
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Minneapolis, 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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HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
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