K050863 is an FDA 510(k) clearance for the IMAGER II ANGIOGRAPHIC CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 2, 2005, 150 days after receiving the submission on April 5, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K050863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2005 |
| Decision Date | September 02, 2005 |
| Days to Decision | 150 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 |