Kaplan-Simpson InfusaSleeve II Catheter

Kaplan-Simpson InfusaSleeve II Catheter is an FDA 510(k)-cleared medical device (K952317) manufactured by Localmed, 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 27, 1995. Regulation: 8.