510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QAQClass II

Adjunctive Predictive Cardiovascular Indicator

21 CFR 870.2210 / Cardiovascular
FDA source (opens on fda.gov)

QAQ is the FDA product code for Adjunctive Predictive Cardiovascular Indicator, a class II device type, regulated under 21 CFR 870.2210. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAQ
Device name
Adjunctive Predictive Cardiovascular Indicator
FDA definition
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.
Regulation
21 CFR 870.2210
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QAQ

By decision year
5 clearances under product code QAQ with a decision year between 2018 and 2025, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QAQ by decision year
YearClearances
20181
20191
20211
20231
20251

Applicants with the most clearances

Product code QAQ
Applicants holding the most 510(k) clearances under product code QAQ
ApplicantClearances
Edwards Lifesciences LLC4
Edwards Lifeciences, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code