Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable is an FDA 510(k)-cleared medical device (K161384) manufactured by Shockwave 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 September 13, 2016. Regulation: 8.