510(k) K220781 ยท EZN Dilator, Catheter, Ureteral
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
| Applicant | Allwin Medical Devices, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, May 5, 2023 |
| Received | Mar 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220781
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.