K020012 is an FDA 510(k) clearance for the MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific/Medi-Tech (Natick,, US). The FDA issued a Cleared decision on January 29, 2002, 26 days after receiving the submission on January 3, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K020012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2002 |
| Decision Date | January 29, 2002 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |