# K020821: Scout (Sinus Cornarius Utility Tool), Model 335 117

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jun 3, 2002 after 82 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K893658 (1989). 8 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001) Summary page 1.

## Most influential descendants
- K033320: Scout Pro (2003), 7 descendants of its own
- 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

## Indications for use
The SCOUT Accessories for Implanting in the Coronary Sinus is for introducing legally marketed leads into the vessels of the left heart via the coronary sinus.

Source page: https://510kreport.com/device/K020821
Methodology: https://510kreport.com/methodology