Dillard Airway Dilatation System— 510(k) K153484
Substantially EquivalentIntuit Medical Products, LLC
FDA 510(k) clearance K153484 for Dillard Airway Dilatation System, Substantially Equivalent on 2016-07-27. Applicant: Intuit Medical Products, LLC.
Clearance details
- Applicant
- Intuit Medical Products, LLC
- Product code
- Code KTI
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sugar Hill, GA, US
Adverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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.