510(k) K021142 ยท EZL Catheter, Retention Type, Balloon
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
| Applicant | Fortune Medical Instrument Corp., Taipei Hsien, TW |
| Decision | Substantially Equivalent, Oct 1, 2002 |
| Received | Apr 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021142
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.