K143041 is an FDA 510(k) clearance for the Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on June 4, 2015, 225 days after receiving the submission on October 22, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K143041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2014 |
| Decision Date | June 04, 2015 |
| Days to Decision | 225 days |
| Submission Type | Special |
| 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 |