Identity
- Trade Name
- VSI Torque Device FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature. FDA UDI
- Model / Reference
- 8181 FDA UDI
- Description
- The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20681810 FDA UDI
- 510(k) Number
- K100093 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Torque manipulation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VSI Torque Device by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100093 also covers:
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 |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI f89b49b2-33ee-4604-bbcf-0f5245354282 36 fields · synced Jun 8, 2026