K000743 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 6, 2000, 183 days after receiving the submission on March 7, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K000743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2000 |
| Decision Date | September 06, 2000 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| 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 |