K043246 is an FDA 510(k) clearance for the BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on February 2, 2005, 71 days after receiving the submission on November 23, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K043246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2004 |
| Decision Date | February 02, 2005 |
| Days to Decision | 71 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 |