Pediatric Ventricular Assist Device
The Pediatric Ventricular Assist Device (VAD) is a life-sustaining implantable device that assists the left or right ventricle in maintaining circulatory blood flow in pediatric patients with severe heart failure. It is referenced under regulation 870.3545 in the Cardiovascular medical specialty. The device carries a class of "f," indicating a special or biological regulatory pathway, reflecting the unique clinical and regulatory challenges of pediatric cardiac support. As both an implant and a life-sustaining device, it is subject to the highest level of regulatory scrutiny.
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Basic Information
- Product Code
- PCK
- Regulation Number
- 870.3545
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 6
Device Characteristics
Definition
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.