NuVent EM Sinus Dilation System— 510(k) K152121
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K152121 for NuVent EM Sinus Dilation System, Substantially Equivalent on 2015-12-01. Applicant: Medtronic Xomed, Inc.. Device class: 1.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code LRC
- Device class
- Class 1
- Regulation
- 21 CFR 874.4420
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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Adverse events under product code LRC
product code LRC- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.