LifePearl Microshperes
FDA 510(k) clearance K150958 · decided 2015-09-17
Clearance details
- K-number
- K150958
- Device name
- LifePearl Microshperes
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-09
- Decision date
- 2015-09-17
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tistin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 mi recall (Z-2188-2025) | MICROVENTION INC. | 2025-07-28 |
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 |