Company ยท US
Prytime Medical Devices, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2025 | K243795 | pREBOA-PRO Catheter Prytime Medical Devices, Inc. | MJN |
| Jun 3, 2020 | K200459 | pREBOA-PRO Catheter Prytime Medical Devices, Inc. | MJN |
| Jan 9, 2020 | K193440 | ER-REBOA PLUS Catheter Prytime Medical Devices, Inc. | MJN |
| Nov 8, 2017 | K172790 | ER-REBOA Catheter Prytime Medical Devices, Inc. | MJN |
| Apr 4, 2017 | K170411 | ER-REBOA Catheter Prytime Medical Devices, Inc. | MJN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2020 | Prytime Medical Devices, Inc. PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C,
Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, Terminated |
OFC | None listed |
| Oct 29, 2020 | Prytime Medical Devices, Inc. PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for tem Terminated |
MJN | K193440 |