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Pediatric Ventricular Assist Device
PCK · f · Cardiovascular · 21 CFR 870.3545
Classification
FDA Product Code PCKDevice class f
Regulation 21 CFR 870.3545
Review panel CV
Medical specialty Cardiovascular
Submission type 6
GMP exempt N
Life sustaining Y
Implant Y
Third-party review N
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.
Market data
Cleared 510(k) submissions 0
Registered establishments 1
Source
Authoritative FDA Device Classification database Machine JSON-LD · Markdown
FDA medical device classification · AI Analytics CC0 1.0