510(k) K193440 ยท MJN Catheter, Intravascular Occluding, Temporary
ER-REBOA PLUS Catheter
| Applicant | Prytime Medical Devices, Inc., Boerne TX, US |
| Decision | Substantially Equivalent, Jan 9, 2020 |
| Received | Dec 11, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.