Submission Details
| 510(k) Number | K143041 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
Jun 2015
Decision
225d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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