K052908 is an FDA 510(k) clearance for the INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Infraredx, Inc. (Burlington, US). The FDA issued a Cleared decision on June 23, 2006, 252 days after receiving the submission on October 14, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K052908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2005 |
| Decision Date | June 23, 2006 |
| Days to Decision | 252 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 |