The following data is part of a premarket notification filed by Conavi Medical Inc. with the FDA for Novasight Hybrid System.
| Device ID | K172258 |
| 510k Number | K172258 |
| Device Name: | Novasight Hybrid System |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Conavi Medical Inc. 293 Lesmill Road Toronto, CA M3b2v1 |
| Contact | Sam Mostafavi |
| Correspondent | Sam Mostafavi Conavi Medical Inc. 293 Lesmill Road Toronto, CA M3b2v1 |
| Product Code | OBJ |
| Subsequent Product Code | IYO |
| Subsequent Product Code | NQQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-26 |
| Decision Date | 2018-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 01628055603053 | K172258 | 000 |
| 00628055603108 | K172258 | 000 |
| 00628055603085 | K172258 | 000 |
| 00628055603078 | K172258 | 000 |
| 00628055603061 | K172258 | 000 |
| 00628055603092 | K172258 | 000 |
| 00628055603115 | K172258 | 000 |