K160941 is an FDA 510(k) clearance for the Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 13, 2016, 253 days after receiving the submission on April 4, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K160941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2016 |
| Decision Date | December 13, 2016 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |