INTHERM RADIALLY EXPANDING DILATING INTRODUCER

INTHERM RADIALLY EXPANDING DILATING INTRODUCER is an FDA 510(k)-cleared medical device (K931489) manufactured by Innerdyne Medical, 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 14, 1993. Regulation: 8.