# K120964: Upstream GR Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Upstream Peripheral Technologies
- Decided: May 25, 2012 after 56 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 K001992 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082339: Enabler-P Support Catheter, Endocross, Ltd. (2008) Summary page 1.

## Indications for use
The Upstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

Source page: https://510kreport.com/device/K120964
Methodology: https://510kreport.com/methodology