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Amplatzer Torq Vue 2 Delivery Sheath (9-Tv2-05f120 +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K093476
Identifiers
- 510(k) Number
- K093476 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- Models / Variants
- 9-Tv2-05f120 FDA 510(k)Model 9-Tv2-06f120 FDA 510(k)Modeltv-2-07f120 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Amplatzer Torq Vue 2 Delivery Sheath (9-Tv2-05f120 +2 more) by Aga Medical Corp. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
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 | K093476 | Class II | Active |
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Manufacturer
- Manufacturer
- Aga Medical Corp.
Sources (1)
- FDA 510(k) K093476 24 fields · synced Jun 19, 2026