# K981886: Vrac High Dose Rate (HDR) Remote Afterloading Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 3, 1998 after 158 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 K945383 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945383: High Dose Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 1.

## Most influential descendants
- K990753: Grac High Dose Rate (HDR) Remote Afterloading Catheter (1999), 0 descendants of its own

## Indications for use
Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

Source page: https://510kreport.com/device/K981886
Methodology: https://510kreport.com/methodology