# K112482: Selectra Slitter Tool

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Sep 26, 2011 after 28 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K112482
Methodology: https://510kreport.com/methodology