HYDROCOIL EMBOLIC SYSTEM (HES)
FDA 510(k) clearance K120908 · decided 2012-04-25
Clearance details
- K-number
- K120908
- Device name
- HYDROCOIL EMBOLIC SYSTEM (HES)
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-26
- Decision date
- 2012-04-25
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tistin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013) | MicroVention, Inc. | 2025-11-02 |
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| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
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| 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 |