SpyGlass Discover Balloon Dilation Catheter— 510(k) K212582
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K212582 for SpyGlass Discover Balloon Dilation Catheter, Substantially Equivalent on 2022-05-06. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code GCA
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.