K163272
Substantially EquivalentAXIOS Stent and Electrocautery Enhanced Delivery System
- Applicant
- Boston Scientific Corporation
- Product code
- PCU
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Adverse events under product code PCU
product code PCU- Death
- 47
- Injury
- 804
- Malfunction
- 709
- Total
- 1,560
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.