# K143459: Silk Road Acccess Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Silk Road Medical, Inc.
- Decided: Apr 1, 2015 after 118 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 K010954 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130649: Silk Road Access Catheter, Silk Road Medical, Inc. (2013) Summary page 4.

## Indications for use
The Silk Road® Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.

Source page: https://510kreport.com/device/K143459
Methodology: https://510kreport.com/methodology