K100892 is an FDA 510(k) clearance for the RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on April 12, 2010, 12 days after receiving the submission on March 31, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K100892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2010 |
| Decision Date | April 12, 2010 |
| Days to Decision | 12 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 |