ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is an FDA 510(k)-cleared medical device (K211476) manufactured by Imperative Care, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2021. Regulation: 8.