FDA 510(k), K202182, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

510(K) Number: K202182
Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Manufacturer: Jake Wolenberg
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number:    870.1250
Classification Product Code:    NRY  
Date Received    08/04/2020
Decision Date    09/02/2020
Decision    Substantially Equivalent (SESE)