# K101282: Scoutpro Hemostatic Valve

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Jul 21, 2010 after 76 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: 6 generations back to K893658 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060807: Scoutpro 7F Coronary Sinus Lead Delivery System, Biotronik, Inc. (2006) Summary page 1.

## 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 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/K101282
Methodology: https://510kreport.com/methodology