EXTRACTOR RX RETRIEVAL BALLOON

EXTRACTOR RX RETRIEVAL BALLOON is an FDA 510(k)-cleared medical device (K041606) manufactured by Boston Scientific Corp. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2004. Regulation: 8.