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HI-TORQUE InfilTrac Guide Wire Family
FDA 510(k)Class II (US FDA 510(k))
510(k) K193126
Identifiers
- 510(k) Number
- K193126 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HI-TORQUE InfilTrac Guide Wire Family is a robust and reliable medical device designed for precise catheter placement, providing superior outcomes in cardiovascular procedures. Its advanced features, including real-time image guidance and high-quality wire insulation, ensure accurate and safe delivery of catheters to complex anatomical locations.
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 | K193126 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA 510(k) K193126 24 fields · synced Jul 14, 2026