510(k) K130804 ยท EZN Dilator, Catheter, Ureteral
UROMAX ULTRA BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, May 22, 2013 |
| Received | Mar 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Boston Scientific Corporation Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):
1. M0062251200,
2. M0062251210,
3. M0062251220,
4. M0062251230,
5. M0062251240,
6. M0062251260,
7. M0062251290,
8. M0062251300,
9. Open, Classified |
EZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.