PREBOA-PRO Catheter
Prytime Medical Devices, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012279212 | 3012279212 | PRYTIME MEDICAL DEVICES, INC. | 1 | N | 2026-01-01 | 575 Union Blvd Suite 107 Lakewood CO US 80228 |
| 3026788751 | 3026788751 | Prytime Medical Devices, Inc. | 1 | N | 2026-01-01 | 12 Upper Balcones Rd. Suite 300 Boerne TX US 78006 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 189819 | 1315632247 | K243795 | pREBOA-PRO Catheter | MJN | 2025-09-05 |
| 315453 | 1315632247 | K243795 | pREBOA-PRO Catheter | MJN | 2025-09-05 |
| 189819 | 1187528055 | K200459 | pREBOA-PRO Catheter | MJN | 2020-06-03 |
| 315453 | 1187528055 | K200459 | pREBOA-PRO Catheter | MJN | 2020-06-03 |
| 189819 | 1866574592 | K193440 | ER-REBOA PLUS Catheter | MJN | 2020-01-09 |
| 315453 | 1866574592 | K193440 | ER-REBOA PLUS Catheter | MJN | 2020-01-09 |
| 189819 | 2013171941 | K151821 | ER-REBOA Catheter | DQY | 2015-10-23 |
| 189819 | 1232614467 | ||||
| 189819 | 1348416222 | ||||
| 315453 | 1348416222 |
Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc
Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc
2025-06-20
2024-10-16
2022-12-15
2018-07-15
2022-12-15
2022-12-15