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Hoover Negative Pressure Access Sheath - IVX-NS-1250
FDA 510(k)Class II (US FDA 510(k))
510(k) K243820
Identifiers
- 510(k) Number
- K243820 FDA 510(k)
- FDA Product Code
- FED FDA 510(k)
- Models / Variants
- Hoover Model #'s IVX-NS-1040 FDA 510(k)IVX-NS-1050 FDA 510(k)IVX-NS-1140 FDA 510(k)IVX-NS-1150 FDA 510(k)IVX-NS-1240 FDA 510(k)IVX-NS-1250 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Hoover Negative Pressure Access Sheath - IVX-NS-1250 by Dornier MedTech America, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 6 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 | K243820 | Class II | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
- FDA Applicant
- Dornier Medtech America
Sources (1)
- FDA 510(k) K243820 24 fields · synced Jun 18, 2026