510(k) K013172 ยท EZL Catheter, Retention Type, Balloon
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
| Applicant | Porges S.A., Le Plessis Robinson Cedex, FR |
| Decision | Substantially Equivalent, Dec 20, 2001 |
| Received | Sep 24, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Coloplast Manufacturing US, LLC X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, Open, Classified |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.