Charter Guidewire Model 45-281, 45-282, 45-283
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103377 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 Charter Guidewire Model 45-281, 45-282, 45-283 is a cardiovascular guidewire device. It is substantially equivalent to a predicate device and was cleared via the FDA 510(k) process under product code DQX.
This device is supplied by Brivant, Ltd. and is intended for use in cardiovascular procedures. It is a single-use device and is not MRI conditional unless otherwise specified; storage and handling should follow manufacturer instructions.
Frequently asked questions
What is the Charter Guidewire Model 45-281, 45-282, 45-283 used for?
The Charter Guidewire Models 45-281, 45-282, and 45-283 are intended for use in cardiovascular procedures, as specified in the device description, to assist in guiding catheters or other devices within the vascular system during intervention.
Is the Charter Guidewire Model 45-281, 45-282, 45-283 a single-use or reusable device?
The device is explicitly stated to be a single-use device and is not designed for reuse; this is indicated in the description under intended use and handling instructions to ensure patient safety and device integrity.
How is the Charter Guidewire Model 45-281, 45-282, 45-283 supplied and by whom?
The Charter Guidewire Models 45-281, 45-282, and 45-283 are supplied by Brivant, Ltd., as listed in the manufacturer and authorization fields, and are distributed as finished sterile single-use units for cardiovascular clinical use.
What regulatory pathway was used for the Charter Guidewire Model 45-281, 45-282, 45-283?
The device was cleared via the FDA 510(k) process, as indicated in the AUTHORIZATIONS field and confirmed in the description, demonstrating substantial equivalence to a predicate device under product code DQX.
Is the Charter Guidewire Model 45-281, 45-282, 45-283 MRI conditional?
The device is not MRI conditional unless otherwise specified, as noted in the description, meaning it has not been tested or labeled for safety in MRI environments and should be considered unsafe for such use without explicit labeling.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103377 | Class II | Active |
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Manufacturer
- Manufacturer
- Brivant, Ltd.
Sources (1)
- FDA 510(k) K103377 24 fields · synced Sep 21, 2026