# K140490: Civa Sheet PD-103

- Pathway: 510(k) (Traditional)
- Applicant: Civatech Oncology, Inc.
- Decided: Aug 29, 2014 after 183 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874787 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082159: Civastring PD-103, Civatech Oncology, Inc. (2008) Summary page 4.

## Indications for use
CivaSheet is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaSheet may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K140490
Methodology: https://510kreport.com/methodology