K994155 is an FDA 510(k) clearance for the EXCELSIOR 1018 MICROCATHETER. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on August 3, 2000, 238 days after receiving the submission on December 9, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K994155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1999 |
| Decision Date | August 03, 2000 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |