# K131978: Selectra Accessory Kit, Selectra Slitter Tool

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Aug 23, 2013 after 56 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: 2 generations back to K101776 (2010). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111839: Selectra Accessory Kit, Biotronik, Inc. (2011) Summary page 1.
- K112482: Selectra Slitter Tool, Biotronik, Inc. (2011) Summary page 1.

## Most influential descendants
- K151409: Selectra Catheters and Selectra Accessory Kit (2015), 5 descendants of its own
- 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

## Indications for use
The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

Source page: https://510kreport.com/device/K131978
Methodology: https://510kreport.com/methodology