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. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
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More clearances from Boston Scientific Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.