K121614 is an FDA 510(k) clearance for the NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER. This device is classified as a Catheter, Nephrostomy.
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on September 18, 2012, 109 days after receiving the submission on June 1, 2012.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K121614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2012 |
| Decision Date | September 18, 2012 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |