Dual Lumen Embolectomy Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970762 FDA 510(k)
- FDA Product Code
- DXE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dual Lumen Embolectomy Catheter is a medical device classified as a catheter designed for embolectomy procedures. It is engineered to remove arterial thromboemboli, providing a means for restoring blood flow in occluded vessels through mechanical intervention. The dual-lumen design facilitates both aspiration and infusion capabilities, enhancing its utility in interventional cardiology settings.
This device is supplied as a sterile, disposable balloon catheter intended for single-use applications. It is regulated under FDA 510(k) clearance (K970762) and falls under the classification of Class II medical devices (DXE). The catheter is intended for use in controlled clinical environments, such as catheterization labs, and adheres to regulatory standards for cardiovascular interventions. No additional sterility or MRI safety information is specified in the provided data.
Frequently asked questions
What is the Dual Lumen Embolectomy Catheter used for?
The Dual Lumen Embolectomy Catheter is designed specifically for embolectomy procedures in interventional cardiology. It mechanically removes arterial thromboemboli—clots blocking blood flow—to restore circulation in occluded vessels. The dual-lumen design allows simultaneous aspiration (suction) and infusion, improving efficiency during clot extraction.
Is the Dual Lumen Embolectomy Catheter sterile and single-use?
Yes, the catheter is supplied as a sterile, disposable device intended exclusively for single-use applications. This ensures patient safety by preventing cross-contamination and maintaining sterility between procedures, which is critical in controlled clinical environments like catheterization labs.
What regulatory pathway does this device follow?
The Dual Lumen Embolectomy Catheter is regulated under the FDA’s 510(k) clearance process (K970762) and is classified as a Class II medical device (product code: DXE). This pathway confirms its substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for cardiovascular interventions.
Where is this catheter intended for use?
This device is intended for use in controlled clinical environments, such as catheterization labs, where interventional cardiology procedures are performed. The design and regulatory classification emphasize its role in specialized settings where precise mechanical clot removal is required to restore arterial blood flow.
Are there specific sizes or models available for this catheter?
While the provided data does not specify exact sizes or model variations, the Dual Lumen Embolectomy Catheter is engineered for flexibility in interventional cardiology. Clinicians typically select the appropriate size based on patient anatomy and procedural requirements, ensuring compatibility with the target vessel and clot composition.
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: DUAL LUMEN EMBOLECTOMY CATHETER (K970762) — FDA 510 (k) | Innolitics, Applied Resources Dual Lumen Embolectomy Catheter, PDF K970762 - Dual Lumen Embolectomy Catheter, PDF PRODUCT CATALOG - Applied Medical, DUAL LUMEN EMBOLECTOMY CATHETER 510(k) K970762 - 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 | K970762 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources
Sources (1)
- FDA 510(k) K970762 24 fields · synced Oct 1, 2026