Model 6615 Floscan Doppler Diagnostic Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K862673 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 6615 Floscan Doppler Diagnostic Catheter is a Catheter, Intravascular, Diagnostic (product code DQO) designed for assessing blood flow and vascular conditions. It incorporates Doppler technology to measure and evaluate hemodynamic parameters within blood vessels, aiding in the diagnosis of cardiovascular disorders.
This device is intended for single-use in clinical settings, including cardiac catheterization labs and interventional radiology. Supplied sterile and classified as Class II under FDA regulations, it requires proper handling and storage as per manufacturer guidelines. Authorized under FDA 510(k) clearance (K862673), it was determined substantially equivalent to a predicate device in 1986.
Frequently asked questions
What clinical settings is the Model 6615 Floscan Doppler Diagnostic Catheter intended for use in?
The Model 6615 Floscan Doppler Diagnostic Catheter is designed for use in clinical environments where vascular assessment is critical, such as cardiac catheterization labs and interventional radiology suites. Its Doppler technology helps evaluate blood flow and hemodynamic parameters within blood vessels, making it useful for diagnosing cardiovascular conditions in these controlled settings.
Is the Model 6615 Floscan Doppler Diagnostic Catheter reusable or single-use, and how should it be handled?
The Model 6615 Floscan Doppler Diagnostic Catheter is explicitly intended for single-use only. Since it is supplied sterile, proper handling and adherence to manufacturer guidelines for storage and use are essential to maintain sterility and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
What types of measurements or evaluations can this catheter perform, and why is Doppler technology important in this context?
The Model 6615 incorporates Doppler technology to measure and evaluate hemodynamic parameters within blood vessels, such as blood flow velocity and patterns. This helps clinicians assess vascular conditions, including blockages, stenosis, or other abnormalities that could indicate cardiovascular disorders. Doppler allows non-invasive evaluation of blood flow dynamics, aiding in accurate diagnostic assessments.
How is the regulatory status of this device determined, and what does the product code (DQO) signify?
The Model 6615 Floscan Doppler Diagnostic Catheter holds FDA 510(k) clearance (K862673), granted in 1986 under the Traditional review pathway by the Cardiovascular (CV) Advisory Committee. The product code DQO classifies it as a Catheter, Intravascular, Diagnostic, indicating its intended use for diagnostic purposes within blood vessels. This classification aligns with its role in assessing vascular conditions.
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: MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER (K862673) — FDA 510(k ..., K862673 - MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC C... | FDA 510(k), Model 6615 Floscan Doppler Diagnostic Catheter 510(k) K862673 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K862673 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K862673 24 fields · synced Oct 6, 2026