K011664 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/Medi-Tech (Natick,, US). The FDA issued a Cleared decision on September 7, 2001, 100 days after receiving the submission on May 30, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K011664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2001 |
| Decision Date | September 07, 2001 |
| Days to Decision | 100 days |
| Submission Type | Special |
| 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 |