The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ilumien System With Aptivue Software Version D.3.
| Device ID | K192267 |
| 510k Number | K192267 |
| Device Name: | ILUMIEN System With AptiVue Software Version D.3 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Contact | Anita Xavier |
| Correspondent | Anita Xavier Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2019-12-17 |