BIPOLAR LEAD ADAPTOR, MODEL BA-415

BIPOLAR LEAD ADAPTOR, MODEL BA-415 is an FDA 510(k)-cleared medical device (K790218) manufactured by Pacesetter 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 August 9, 1979. Regulation: 8.