Progress Guide Wire Family, Pilot Guide Wire Family
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123067 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 Progress Guide Wire Family and Pilot Guide Wire Family are guide wires used in catheter procedures, providing support and flexibility for navigating challenging anatomy and lesions. They offer a range of features such as varying tip loads, tip tapers, penetration powers, coatings, and covers. These guide wires are designed to facilitate superb crossing performance, particularly in complex and calcified lesions. The device type is a wire, guide, catheter.
The Progress Guide Wire Family and Pilot Guide Wire Family are supplied with various specifications, including a product code of DQX. They have been authorized with an FDA 510K clearance, with a substantially equivalent decision. The devices are associated with the k number K123067 and are classified under the advisory committee for Cardiovascular devices.
Frequently asked questions
What are the Progress Guide Wire Family and Pilot Guide Wire Family used for?
They are used in catheter procedures to provide support and flexibility for navigating challenging anatomy and lesions, facilitating superb crossing performance.
What features do the guide wires offer?
They offer varying tip loads, tip tapers, penetration powers, coatings, and covers to facilitate navigation of complex and calcified lesions.
How are the guide wires supplied?
They are supplied with various specifications, including a product code of DQX.
What is the regulatory status of the guide wires?
They have been authorized with an FDA 510K clearance, with a substantially equivalent decision, and are classified under the advisory committee for Cardiovascular devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Coronary Specialty Guide Wires | Abbott, Abbott Peripheral Interventional Guidewires, Abbott > Guidewires - Incathlab, www.accessdata.fda.gov, Abbott Coronary Guidewire Pilot Family | IMT Medical Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123067 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA 510(k) K123067 24 fields · synced Sep 22, 2026