ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is an FDA 510(k)-cleared medical device (K202182) 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 September 1, 2020. Regulation: 8.