R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD is an FDA 510(k)-cleared medical device (K935371) manufactured by R2 Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 1994. Regulation: 8.