Identity
- Trade Name
- HI-TORQUE INTERMEDIATE FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- HI-TORQUE Intermediate Guide Wire w/Hydrocoat .014 Straight 3.0 cm x 190 cm FDA UDI
- Model / Reference
- 22317H FDA UDI
- Description
- HI-TORQUE Intermediate Guide Wire w/Hydrocoat .014 Straight 3.0 cm x 190 cm FDA UDI
Identifiers
- Catalog Number
- 22317H FDA UDI
- Primary DI / UDI-DI
- 08717648079757 FDA UDI
- 510(k) Number
- K974773 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use 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
No
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
Hi-Torque Intermediate by Abbott Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K974773 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
- Abbott Vascular
Sources (1)
- FDA UDI 38c809c8-fa26-4c59-a251-01ba8c63a8fb 38 fields · synced Jun 8, 2026