# K111839: Selectra Accessory Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Sep 26, 2011 after 89 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: 1 generation back to K101776 (2010). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101776: Scoutpro Acs, Biotronik, Inc. (2010) Summary page 1.

## Most influential descendants
- K131978: Selectra Accessory Kit, Selectra Slitter Tool (2013), 6 descendants of its own
- 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

## Indications for use
The Selectra accessory kit 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/K111839
Methodology: https://510kreport.com/methodology