Identity
- Trade Name
- VSI Micro-HV Introducer Kit FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- VSI Micro-HV Introducer Kit FDA UDI
- Model / Reference
- CLI-800-28 FDA UDI
- Description
- VSI Micro-HV Introducer Kit FDA UDI
Identifiers
- Catalog Number
- CLI-800-28 FDA UDI
- Primary DI / UDI-DI
- 00841268106581 FDA UDI
- 510(k) Number
- K043525 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Category: Haemostasis valve
VSI Micro-HV Introducer Kit by Galt Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemostasis valve.
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Cleared under the same submission
K043525 also covers:
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Radial Micro-HV Introducer Kit — Galt Medical Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Galt Medical Corp.
Sources (1)
- FDA UDI 6a809105-6ba9-4e2e-8f74-872124de4431 37 fields · synced May 30, 2026