Reprocessed BRK Transseptal Needle

Reprocessed BRK Transseptal Needle is an FDA 510(k)-cleared medical device (K192998) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2020. Regulation: 8.