
Datascope Corp.
Free shipping on orders over $99 · 30-day returns
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K063525) 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 January 4, 2007. Regulation: 8.