SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE

SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE is an FDA 510(k)-cleared medical device (K130843) manufactured by Oscor, 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 January 7, 2014. Regulation: 8.