# K222037: Selectra Lead Implantation System

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Jul 19, 2022 after 8 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: 7 generations back to K101776 (2010). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192996: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool, Biotronik, Inc. (2019) Summary page 4.
- K193474: Selectra 3D Outer Guiding Catheters, Biotronik, Inc. (2020) Summary page 4.

## Most influential descendants
- K240787: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (2024), 0 descendants of its own

## Indications for use
In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.

Source page: https://510kreport.com/device/K222037
Methodology: https://510kreport.com/methodology