# K162467: Twin-Pass Torque

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 1, 2017 after 152 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 K010579 (2001). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter,, Vascular Solutions, Inc. (2009) Summary page 4.

## Most influential descendants
- K200324: NHancer Rx (2020), 1 descendant of its own
- K210431: ReCross (2021), 0 descendants of its own

## Indications for use
The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Source page: https://510kreport.com/device/K162467
Methodology: https://510kreport.com/methodology