Edwards Lifesciences Research Medical Pediatric Arterial Cannulae
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033463 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 Edwards Lifesciences Research Medical Pediatric Arterial Cannulae are vascular catheters designed for cardiopulmonary bypass procedures. These cannulae are specifically indicated for perfusion of the aorta or femoral artery during procedures requiring cardiopulmonary bypass.
The device is supplied as a Class II medical device under product code DWF with FDA 510(k) clearance. The Edwards Lifesciences Research Medical Pediatric Arterial Cannulae are manufactured by Edwards Lifesciences LLC in Irvine, California, and are available in various sizes as indicated by the multiple registration numbers associated with this device.
Frequently asked questions
What are the Edwards Lifesciences Research Medical Pediatric Arterial Cannulae used for?
These vascular catheters are specifically designed for cardiopulmonary bypass procedures, indicated for perfusion of the aorta or femoral artery during procedures requiring cardiopulmonary bypass.
What sizes are available for the Edwards Pediatric Arterial Cannulae?
The Edwards Lifesciences Research Medical Pediatric Arterial Cannulae are available in various sizes, as indicated by the multiple registration numbers associated with this device, allowing for appropriate selection based on patient needs.
What is the regulatory status of the Edwards Pediatric Arterial Cannulae?
The device is supplied as a Class II medical device under product code DWF with FDA 510(k) clearance, manufactured by Edwards Lifesciences LLC in Irvine, California.
How are the Edwards Pediatric Arterial Cannulae supplied?
The Edwards Lifesciences Research Medical Pediatric Arterial Cannulae are manufactured by Edwards Lifesciences LLC and are available in various sizes, with multiple registration numbers indicating different size options for clinical use.
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: K033463 FDA 510(k) - EDWARDS LIFESCIENCES RESEARCH MEDICAL P..., Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences Research Medical Pediatric Arterial Cannulae ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033463 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K033463 24 fields · synced Sep 26, 2026