# K033320: Scout Pro

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Nov 19, 2003 after 35 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: 4 generations back to K893658 (1989). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020821: Scout (Sinus Cornarius Utility Tool), Model 335 117, Biotronik, Inc. (2002) Summary page 1.

## Most influential descendants
- K060807: Scoutpro 7F Coronary Sinus Lead Delivery System (2006), 5 descendants of its own
- K071665: Scoutpro Slitter Tool Advanced, Model 356 552 (2007), 3 descendants of its own
- K060655: Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter, Models 342 263; Multi-Purpose H (2006), 3 descendants of its own
- K072329: Scoutpro 8F, 7F and Slitter Tool Advanced (2008), 2 descendants of its own
- K101282: Scoutpro Hemostatic Valve (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K033320
Methodology: https://510kreport.com/methodology