510(k) K172258 ยท OBJ Catheter, Ultrasound, Intravascular
Novasight Hybrid System
| Applicant | Conavi Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Apr 27, 2018 |
| Received | Jul 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2025 | Conavi Medical Inc. Brand Name: Novasight Hybrid System
Product Name: Novasight Hybrid Catheter
Model/Catalog Number: TA-06-0001
Product Description: Common Name: Diagnostic intravascular catheter
Description: The Novasi Open, Classified |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.