FDA 510(k), K210996, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
FDA 510(k), K210996, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
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$149.00 USD
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$149.00 USD
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510(K) Number: K210996
Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 04/02/2021
Date Received: 04/23/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 04/02/2021
Date Received: 04/23/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology