DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER

DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER is an FDA 510(k)-cleared medical device (K901391) manufactured by Datascope Corp.. 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 25, 1990. Regulation: 8.