SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH

SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH is an FDA 510(k)-cleared medical device (K910155) manufactured by Scimed Life Systems, 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 February 6, 1991. Regulation: 8.