NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER— 510(k) K121614

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K121614 for NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER, Substantially Equivalent on 2012-09-18. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LJE
Advisory panel: Unknown
Date received: 2012-06-01
Decision date: 2012-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.