# K211802: GoBack Crossing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Upstream Peripheral Technologies, Ltd.
- Decided: Mar 1, 2022 after 264 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 2 generations back to K001577 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182937: Upstream GoBack Crossing Catheter, Upstream Peripheral Technologies, Ltd. (2019) Summary page 4.

## Indications for use
The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

Source page: https://510kreport.com/device/K211802
Methodology: https://510kreport.com/methodology