The following data is part of a premarket notification filed by Crossbay Medical with the FDA for Crossbay Cervical Dilator Catheter System.
| Device ID | K190813 |
| 510k Number | K190813 |
| Device Name: | CrossBay Cervical Dilator Catheter System |
| Classification | Catheter, Balloon, Dilation Of Cervical Canal |
| Applicant | CrossBay Medical 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 | PON |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35420045512430 | K190813 | 000 |
| 25420045512426 | K190813 | 000 |
| 35420045512416 | K190813 | 000 |