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FDA 510(k), K213565, JETi AIO Peripheral Thrombectomy System
FDA 510(k), K213565, JETi AIO Peripheral Thrombectomy System
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$89.00 USD
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510(K) Number: K213565
Device Name: JETi AIO Peripheral Thrombectomy System
Manufacturer: Namratha Manthani
Device Classification Name: Aspiration Thrombectomy Catheter
Regulation Number: QEZ
Classification Product Code: KXA
Date Received: 11/09/2021
Decision Date: 02/01/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: JETi AIO Peripheral Thrombectomy System
Manufacturer: Namratha Manthani
Device Classification Name: Aspiration Thrombectomy Catheter
Regulation Number: QEZ
Classification Product Code: KXA
Date Received: 11/09/2021
Decision Date: 02/01/2022
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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