Embozene Color-Advanced Microspheres— 510(k) K180102
Substantially EquivalentBoston Scientific
FDA 510(k) clearance K180102 for Embozene Color-Advanced Microspheres, Substantially Equivalent on 2018-04-19. Applicant: Boston Scientific. Device class: 2.
Clearance details
- Applicant
- Boston Scientific
- Product code
- Code NOY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5550
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code NOY
view all- K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
- K192684 — HydroPearl Microspheres
- DEN160040 — Embosphere Microspheres
More clearances from Boston Scientific
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