Heart-Valve, Mechanical
The Mechanical Heart Valve (product code LWQ) is a prosthetic device surgically implanted to replace a diseased or damaged heart valve, using mechanical components (such as a ball, disc, or bileaflet design) to replicate the one-directional blood flow function of a natural valve. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as both an implant and a life-sustaining device due to its critical role in maintaining cardiac circulation. The device is reviewed under the Cardiovascular (CV) panel. No regulation number has been formally assigned.
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Basic Information
- Product Code
- LWQ
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.