LeMaitre 8F Occlusion Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132022 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LeMaitre 8F Occlusion Catheter is an intravascular, temporary occlusion device designed for temporary vessel occlusion. It features a single-lumen catheter with a latex balloon available in two sizes (28 mm or 45 mm) and includes radiopaque marker bands for fluoroscopic visualization. This device is classified as a Class II medical device under FDA regulations (870.4450).
The catheter is supplied sterile and intended for single-use in clinical settings, such as vascular procedures. It includes a stopcock for maintaining balloon inflation and is compatible with fluoroscopic imaging. The device holds an FDA 510(k) clearance (K132022) under the Traditional 510(k) Review process, with a decision date of November 6, 2013. No MRI safety information is specified.
Frequently asked questions
What is the LeMaitre 8F Occlusion Catheter used for?
The LeMaitre 8F Occlusion Catheter is designed for temporary vessel occlusion during vascular procedures. Its single-lumen design with a latex balloon allows controlled blockage of blood flow, which can be useful in procedures requiring isolation of a specific vessel segment. The radiopaque marker bands enable real-time visualization under fluoroscopy, ensuring precise placement and inflation control.
How is the LeMaitre 8F Occlusion Catheter supplied, and is it sterile?
The catheter is supplied sterile and intended for single-use only, adhering to clinical best practices for infection control. It comes pre-packaged, ready for immediate use in procedural settings without requiring additional sterilization. The sterile packaging ensures safety and reliability for one-time deployment.
What balloon sizes are available, and how does the stopcock function?
The LeMaitre 8F Occlusion Catheter offers two balloon sizes: 28 mm or 45 mm, allowing clinicians to select the appropriate occlusion diameter based on the patient’s anatomy. The included stopcock facilitates precise control over balloon inflation and deflation, enabling sustained occlusion during procedures while minimizing the risk of overinflation or leakage.
Can this catheter be reused, and what are the storage requirements?
The catheter is explicitly designed for single-use only, as outlined in its intended use and regulatory classification. Reuse is not recommended or supported by the manufacturer to maintain sterility and performance. Storage should follow the manufacturer’s guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures, ensuring the packaging remains intact until use.
Is fluoroscopic imaging compatible with this catheter, and are there any MRI safety considerations?
Yes, the LeMaitre 8F Occlusion Catheter is compatible with fluoroscopic imaging due to its radiopaque marker bands, which enhance visibility under X-ray guidance. However, no MRI safety information is specified for this device, meaning it should not be used in or near MRI environments unless explicitly cleared for such use by the manufacturer. Always verify compatibility with your facility’s MRI protocols.
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: LEMAITRE 8F OCCLUSION CATHETER (K132022) — FDA 510 (k) | Innolitics, Home | LeMaitre, R2536-01 Rev. L.indd - LeMaitre
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132022 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA 510(k) K132022 24 fields · synced Oct 1, 2026