K140329 is an FDA 510(k) clearance for the RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on May 15, 2014, 94 days after receiving the submission on February 10, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K140329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2014 |
| Decision Date | May 15, 2014 |
| Days to Decision | 94 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |