The following data is part of a premarket notification filed by Prytime Medical Devices, Inc. with the FDA for Preboa-pro Catheter.
| Device ID | K200459 |
| 510k Number | K200459 |
| Device Name: | PREBOA-PRO Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Prytime Medical Devices, Inc. 229 North Main Street Boerne, TX 78006 |
| Contact | Brian Young |
| Correspondent | Brian Young Prytime Medical Devices, Inc. 229 North Main Street Boerne, TX 78006 |
| Product Code | MJN |
| Subsequent Product Code | DQO |
| Subsequent Product Code | DQY |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001105064 | K200459 | 000 |