# K990753: Grac High Dose Rate (HDR) Remote Afterloading Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: May 27, 1999 after 80 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: 2 generations back to K945383 (1995). 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)
- K945383: High Dose Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 3.
- K981886: Vrac High Dose Rate (HDR) Remote Afterloading Catheter, Cook, Inc. (1998) Summary page 3.

## Indications for use
Used for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.

Source page: https://510kreport.com/device/K990753
Methodology: https://510kreport.com/methodology