The following data is part of a premarket notification filed by Conavi Medical Inc. with the FDA for Foresight Intracardiac Echocardiology (ice) System.
| Device ID | K162789 |
| 510k Number | K162789 |
| Device Name: | Foresight Intracardiac Echocardiology (ICE) System |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Conavi Medical Inc. 293 Lesmill Road Toronto, CA M3b 2v1 |
| Contact | Sam Mostafavi |
| Correspondent | Sam Mostafavi Conavi Medical Inc. 293 Lesmill Road Toronto, CA M3b 2v1 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-04 |
| Decision Date | 2017-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055603047 | K162789 | 000 |
| 00628055603030 | K162789 | 000 |
| 00628055603023 | K162789 | 000 |
| 01628055603015 | K162789 | 000 |