
Biotronik, GmbH & Co.
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PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 is an FDA 510(k)-cleared medical device (K000763) manufactured by Biotronik, GmbH & Co.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 5, 2000. Regulation: 8.