# K110461: Selectra CS Lead Introducer System

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Apr 20, 2011 after 62 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.
8 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)
- K101776: Scoutpro Acs, Biotronik, Inc. (2010) Summary page 1.

## Most influential descendants
- K123324: Selectra 7F Catheters (2013), 6 descendants of its own
- K111154: Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 (2011), 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

## 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/K110461
Methodology: https://510kreport.com/methodology