510(k) K121614 ยท LJE Catheter, Nephrostomy
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Sep 18, 2012 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2025 | Boston Scientific Corporation Boston Scientific NephroMax Kit, Material Numbers (UPN):
1. M0062101180;
2. M0062101600.
(Urology) Open, Classified |
LJE | None listed |
| Jul 9, 2013 | Boston Scientific Corporation NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144
Dilation of the nephrostomy tract. Terminated |
LJE | None listed |
| Jul 9, 2013 | Boston Scientific Corporation NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164
Dilation of the nephrostomy tract. Terminated |
LJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.