K063312 is an FDA 510(k) clearance for the MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on November 30, 2006, 28 days after receiving the submission on November 2, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K063312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2006 |
| Decision Date | November 30, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |