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FDA 510(k), K212632, ClotTriever Thrombectomy System
FDA 510(k), K212632, ClotTriever Thrombectomy System
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510(K) Number: K212632
Device Name: ClotTriever Thrombectomy System
Manufacturer: Larry Boucher
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 08/19/2021
Decision Date: 10/18/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ClotTriever Thrombectomy System
Manufacturer: Larry Boucher
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 08/19/2021
Decision Date: 10/18/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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