# K060655: Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter, Models 342 263; Multi-Purpose H

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Apr 4, 2006 after 22 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: 5 generations back to K893658 (1989). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033320: Scout Pro, Biotronik, Inc. (2003) Summary page 1.

## Most influential descendants
- K072329: Scoutpro 8F, 7F and Slitter Tool Advanced (2008), 2 descendants of its own
- K093303: Scoutpro 7F Long Catheters (2009), 0 descendants of its own
- K080988: Scoutpro CS Lead Introducer System (2008), 0 descendants of its own

## Indications for use
The intended use of the ScoutPro 8F is for introducing leads into the vessels of the left heart via the coronary sinus.

Source page: https://510kreport.com/device/K060655
Methodology: https://510kreport.com/methodology