ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV is an FDA 510(k)-cleared medical device (K861238) manufactured by Angiomedics, 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 July 15, 1986. Regulation: 8.