The following data is part of a premarket notification filed by Prytime Medical Devices, Inc with the FDA for Er-reboa Catheter.
| Device ID | K170411 |
| 510k Number | K170411 |
| Device Name: | ER-REBOA 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 | 2017-02-10 |
| Decision Date | 2017-04-04 |
| Summary: | summary |