# K080988: Scoutpro CS Lead Introducer System

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: May 7, 2008 after 30 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: 8 generations back to K893658 (1989). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060655: Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter, Models 342 263; Multi-Purpose H, Biotronik, Inc. (2006) Summary page 1.
- K060807: Scoutpro 7F Coronary Sinus Lead Delivery System, Biotronik, Inc. (2006) Summary page 2.
- K071665: Scoutpro Slitter Tool Advanced, Model 356 552, Biotronik, Inc. (2007) Summary page 2.
- K072329: Scoutpro 8F, 7F and Slitter Tool Advanced, Biotronik, Inc. (2008) Summary page 2.

## Indications for use
The ScoutPro CS Lead Introducer System facilitates lead implantation in the left of the heart via the coronary sinus. The ScoutPro accessories are used in conjunction with the ScoutPro 8F CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

Source page: https://510kreport.com/device/K080988
Methodology: https://510kreport.com/methodology