510(k) K142635 ยท EZL Catheter, Retention Type, Balloon
Medline Silicone Foley Catheter
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Jan 9, 2015 |
| Received | Sep 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Medline Industries Inc SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urin Terminated |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.