Zoom System (Zoom 4S Catheter)

Zoom System (Zoom 4S Catheter) is an FDA 510(k)-cleared medical device (K252046) 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 October 29, 2025. Regulation: 8.