# K183265: Selectra Catheters, Selectra Accessory Kit

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Dec 13, 2018 after 20 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: 4 generations back to K101776 (2010). 8 ancestors in all.
4 later devices descend 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)
- K123324: Selectra 7F Catheters, Biotronik, Inc. (2013) Summary page 4.
- K151409: Selectra Catheters and Selectra Accessory Kit, Biotronik, Inc. (2015) Summary page 4.
- K131978: Selectra Accessory Kit, Selectra Slitter Tool, Biotronik, Inc. (2013) Summary page 4.
- K112482: Selectra Slitter Tool, Biotronik, Inc. (2011) Summary page 4.

## Most influential descendants
- K192996: Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool (2019), 3 descendants of its own
- 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/K183265
Methodology: https://510kreport.com/methodology