
Biotronik, Inc.
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Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) is an FDA 510(k)-cleared medical device (K240787) manufactured by Biotronik, 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 September 11, 2024. Regulation: 8.

ADC
SKU DX606933

MDF
SKU DX683863

3M Littmann
SKU DX771242

Welch Allyn
SKU DX297280