510(k) K180102
- Device
- Embozene Color-Advanced Microspheres
- Applicant
- Boston Scientific
- 510(k) number
- K180102
- Product code
- NOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-19
- Date received
- 2018-01-16
- Regulation
- 876.5550
- Classification name
- Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Heidi Shearer
- Address
- 3 Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3012536737
- 3005111382
- 3015309643
- 3008262715
- 1225687
- 2124215
- 3013556777
- 9615728
- 2134265
- 3033589330
- 9616684
Source Documents#
Other 510(k) Records For Product Code NOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 |
| K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020-01-22 |
| DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017-06-21 |
Legacy Summary#
summary
FDA Review#
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