K192267 is an FDA 510(k) clearance for the ILUMIEN System with AptiVue Software version D.3. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Abbott Medical (Westford, US). The FDA issued a Cleared decision on December 17, 2019, 118 days after receiving the submission on August 21, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K192267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2019 |
| Decision Date | December 17, 2019 |
| Days to Decision | 118 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 |