HydroPearl Microspheres
FDA 510(k) clearance K192684 · decided 2020-01-22
Clearance details
- K-number
- K192684
- Device name
- HydroPearl Microspheres
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-26
- Decision date
- 2020-01-22
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- NOY
- Device class
- 2
- Regulation number
- 876.5550
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) (K203276) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 |
| Embozene Color-Advanced Microspheres (K180102) | Boston Scientific | 2018-04-19 |
| Embosphere Microspheres (DEN160040) | Biosphere Medical, S.A. | 2017-06-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 recall (Z-0868-2024) | MICROVENTION INC. | 2024-01-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013) | MicroVention, Inc. | 2025-11-02 |
| Flow Re-Direction Endoluminal Device (FRED) X System (P180027/S012) | MicroVention, Inc. | 2025-09-20 |
| FRED X System (P180027/S014) | MicroVention, Inc. | 2025-09-18 |
| Roadsaver/CASPER Carotid Stent Device (P210030/S001) | MicroVention, Inc. | 2025-06-23 |
| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S017) | MicroVention, Inc. | 2024-09-23 |
| Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr (P170013/S012) | MicroVention, Inc. | 2024-08-21 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S011) | MicroVention, Inc. | 2024-08-21 |