# K192996: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Nov 21, 2019 after 24 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: 5 generations back to K101776 (2010). 9 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K183265: Selectra Catheters, Selectra Accessory Kit, Biotronik, Inc. (2018) Summary page 4.

## Most influential descendants
- K193474: Selectra 3D Outer Guiding Catheters (2020), 2 descendants of its own
- K222037: Selectra Lead Implantation System (2022), 1 descendant of its own
- 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
The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Source page: https://510kreport.com/device/K192996
Methodology: https://510kreport.com/methodology