# K080791: Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Apr 30, 2008 after 41 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: 7 generations back to K864210 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071229: Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy, Senorx, Inc. (2007) Summary page 1.

## Indications for use
The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Source page: https://510kreport.com/device/K080791
Methodology: https://510kreport.com/methodology