# K151409: Selectra Catheters and Selectra Accessory Kit

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Aug 7, 2015 after 73 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: 3 generations back to K101776 (2010). 7 ancestors in all.
5 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.
- K111154: Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75, Biotronik, Inc. (2011) Summary page 4.
- K131978: Selectra Accessory Kit, Selectra Slitter Tool, Biotronik, Inc. (2013) Summary page 4.

## Most influential descendants
- K183265: Selectra Catheters, Selectra Accessory Kit (2018), 4 descendants of its own
- 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 CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Source page: https://510kreport.com/device/K151409
Methodology: https://510kreport.com/methodology