# K171631: Standard Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Feb 9, 2018 after 252 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952913 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952913: Applicators for Varian Varisource Remote High Soes Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 5.

## Indications for use
The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

Source page: https://510kreport.com/device/K171631
Methodology: https://510kreport.com/methodology