Supreme and Response Electrophysiology Catheters

Supreme and Response Electrophysiology Catheters is an FDA 510(k)-cleared medical device (K161272) manufactured by Surgical Instrument Service and Savings, 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 May 17, 2017. Regulation: 8.