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Hyperglide Occlusion Balloon System
FDA 510(k)Class II (US FDA 510(k))
510(k) K090728
by Ev3, Inc
Identifiers
- 510(k) Number
- K090728 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Hyperglide Occlusion Balloon System by Ev3, Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090728 | Class II | Active |
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Manufacturer
- Manufacturer
- Ev3, Inc
- FDA Applicant
- Ev3, Inc.
Sources (1)
- FDA 510(k) K090728 24 fields · synced Jun 18, 2026