inforMED
QAQClass II

Adjunctive Predictive Cardiovascular Indicator

Cardiovascular · 21 CFR 870.2210

The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

MDR events31All time
Recalls0All time
Registered firms38Currently listed
510(k) clearances5All time

Recent MDR events

31 adverse event reports on file

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Event type breakdown

Malfunction30
Injury1

Most-reported manufacturers

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Edwards Lifesciences17Edwards Lifesciences Dr12Unspecified1Edwards Lifesciences Llc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

38 firms currently registered for this product code

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510(k) clearances

5 clearances for this product code

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