510(k) K181814 ยท EZL Catheter, Retention Type, Balloon
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
| Applicant | Amsino International, Inc., Pomona CA, US |
| Decision | Substantially Equivalent, Sep 4, 2018 |
| Received | Jul 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181814
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.