510(k) DEN160040
- Device
- Embosphere Microspheres
- Applicant
- Biosphere Medical, S.A.
- 510(k) number
- DEN160040
- Product code
- NOY
- Decision
- Unknown (DENG)
- Decision date
- 2017-06-21
- Date received
- 2016-08-05
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alix Fonlladosa
- Address
- A Wholly Owned Subsidiary Of Merit Medical Systems Inc. Parc Des Nations-Paris Nord 2 383 Rue De La Belle Etoile FR 95700 95700
FDA Registration Numbers#
- 3012536737
- 3005111382
- 3015309643
- 3008262715
- 1225687
- 2124215
- 3013556777
- 9615728
- 2134265
- 3033589330
- 9616684
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | 2018-04-19 |