SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT— 510(k) K131709
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K131709 for SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT, Substantially Equivalent on 2013-10-04. Applicant: Arthrocare Corp.. Device class: 1.
Clearance details
- Applicant
- Arthrocare Corp.
- 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
- Special
- Location
- Austin, TX, 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.