K140490 is an FDA 510(k) clearance for the CIVA SHEET PD-103. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Civatech Oncology, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on August 29, 2014, 183 days after receiving the submission on February 27, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K140490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2014 |
| Decision Date | August 29, 2014 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXK - Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |