# K101776: Scoutpro Acs

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Jul 23, 2010 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.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110461: Selectra CS Lead Introducer System (2011), 8 descendants of its own
- K111839: Selectra Accessory Kit (2011), 7 descendants of its own
- K131978: Selectra Accessory Kit, Selectra Slitter Tool (2013), 6 descendants of its own
- 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

## Indications for use
The ScoutPro ACS guiding catheters are used in conjunction with the ScoutPro ACS CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus. The ScoutPro ACS accessory kit is used in conjunction with the ScoutPro ACS 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/K101776
Methodology: https://510kreport.com/methodology