RELIEVA SINUS BALLOON DILATION CATHETER— 510(k) K043527

Substantially Equivalent

Exploramed Nc1, Inc.

FDA 510(k) clearance K043527 for RELIEVA SINUS BALLOON DILATION CATHETER, Substantially Equivalent on 2005-04-05. Applicant: Exploramed Nc1, Inc..

Clearance details

Applicant: Exploramed Nc1, Inc.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2004-12-21
Decision date: 2005-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

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.