EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
FDA 510(k) clearance K222694 · decided 2023-04-27
Clearance details
- K-number
- K222694
- Device name
- EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-06
- Decision date
- 2023-04-27
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Roadsaver/CASPER Carotid Stent System (P210030/S002) | MicroVention, Inc. | 2026-07-07 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S022) | MicroVention, Inc. | 2026-05-28 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S021) | MicroVention, Inc. | 2026-05-01 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S019) | MicroVention, Inc. | 2026-03-20 |
| 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 |