Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle— 510(k) K163248
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K163248 for Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle, Substantially Equivalent on 2017-03-27. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code EOQ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.