# K240787: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Sep 12, 2024 after 174 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K101776 (2010). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222037: Selectra Lead Implantation System, Biotronik, Inc. (2022) Summary page 5.

## Indications for use
The lead delivery system, consisting of Selectra catheters in conjunction with the Selectra Accessory Kit, is used to facilitate implantation of leads in the heart chambers or in the coronary veins via the coronary sinus. Selectra 3D catheters are also indicated to facilitate Solia S lead implantation in the left bundle branch area to achieve left bundle area pacing (LBBAP).

Source page: https://510kreport.com/device/K240787
Methodology: https://510kreport.com/methodology