The following data is part of a premarket notification filed by Crossbay Medical Inc. with the FDA for Crossbay Ivf Embryo Transfer Catheter Set.
| Device ID | K162064 |
| 510k Number | K162064 |
| Device Name: | CrossBay IVF Embryo Transfer Catheter Set |
| Classification | Catheter, Assisted Reproduction |
| Applicant | CrossBay Medical Inc. 13240 Evening Creek Drive, Suite 304 San Diego, CA 92128 |
| Contact | Piush Vidyarthi |
| Correspondent | Cindy Domecus Domecus Consulting Services, LLC 1171 Barroihet Drive Hillsborough, CA 94010 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2017-01-05 |
| Summary: | summary |