Prytime Medical Devices, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0959-2021 | Class II | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOG | December 14, 2020 |
| Z-0716-2021 | Class II | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr intro | October 29, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243795 | pREBOA-PRO Catheter | September 5, 2025 |
| K200459 | pREBOA-PRO Catheter | June 3, 2020 |
| K193440 | ER-REBOA PLUS Catheter | January 9, 2020 |
| K172790 | ER-REBOA Catheter | November 8, 2017 |
| K170411 | ER-REBOA Catheter | April 4, 2017 |