Fem-Flex and Fem-Flex II Femoral Access Cannulae
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140208 FDA 510(k)
- FDA Product Code
- DWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4210 FDA 510(k)
- Regulation Number
- 870.4210 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fem-Flex and Fem-Flex II Femoral Access Cannulae are vascular cannulae designed for femoral arterial access during cardiopulmonary bypass (CPB). These devices facilitate blood flow between the patient and the extracorporeal circuit, supporting cardiac procedures requiring temporary circulatory assistance. They are categorized as vascular cannulas and tubing for cardiopulmonary bypass applications.
These cannulae are intended for single-use in both pediatric and adult patients, with variations including vented or non-vented connectors. They are supplied sterile and are classified under FDA 510(k) clearance (K140208) as substantially equivalent, with regulatory classification as Class II devices. Compliance with FDA regulations (870.4210) ensures their suitability for use in controlled clinical settings, such as operating rooms or cardiac catheterization labs.
Frequently asked questions
Are these cannulae reusable or designed for single-use only, and how does that affect their clinical use?
The Fem-Flex and Fem-Flex II Femoral Access Cannulae are explicitly designed for single-use only, as stated in the device description. This design ensures sterility and reduces the risk of contamination or cross-infection between patients, which is critical in controlled clinical settings like operating rooms or cardiac catheterization labs. Single-use also simplifies inventory management and eliminates the need for reprocessing, ensuring consistent performance and compliance with medical best practices.
What types of connectors are available for these cannulae, and how might that impact my procedure?
The Fem-Flex and Fem-Flex II cannulae come in variations with vented or non-vented connectors, as mentioned in the description. The choice between these types depends on your procedural needs: vented connectors may help manage air or gas within the circuit, while non-vented connectors provide a simpler, sealed connection. This flexibility allows you to select the configuration that best aligns with your specific cardiopulmonary bypass setup and patient requirements.
Are these cannulae suitable for both pediatric and adult patients, and if so, how are they differentiated?
Yes, the Fem-Flex and Fem-Flex II cannulae are designed for use in both pediatric and adult patients, as noted in the description. While the data does not specify exact sizing variations, the product line likely includes multiple sizes to accommodate different patient demographics. For precise sizing, refer to the manufacturer’s catalog or technical documentation, which would detail the available models (e.g., FEMTRAK, VFEM) and their intended use cases for optimal fit and functionality.
How should these cannulae be stored, and what precautions should be taken to maintain their sterility?
Since these cannulae are supplied sterile, they must be stored in their original, unopened packaging to preserve sterility until use. The packaging should be kept in a clean, dry environment, protected from direct sunlight, moisture, or extreme temperatures. Avoid exposing the packaging to contaminants or physical damage, as this could compromise sterility. Always follow the manufacturer’s storage instructions to ensure the device remains safe and effective for its intended single-use application.
What regulatory pathway was followed for these cannulae, and what does that mean for their use in clinical settings?
The Fem-Flex and Fem-Flex II cannulae were cleared through the FDA 510(k) process, specifically under clearance number K140208, with a determination of substantial equivalence (SESE) to a predicate device. This classification places them in FDA Class II, indicating they pose moderate risk and require compliance with FDA regulations (e.g., 870.4210). Clinically, this means they undergo rigorous review for safety and performance, ensuring they meet established standards for use in cardiopulmonary bypass procedures in controlled settings like operating rooms or catheterization labs.
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: Ferm-flex and Fem-flex Ii ( Femoral Access Arterial Cannulae) Femtrak ..., Fem-Flex II Femoral Arterial Cannulae - Edwards Lifesciences - PDF ..., Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140208 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K140208 24 fields · synced Oct 6, 2026