Panels › Cardiovascular › Product code QAQ · Class 2
Adjunctive Predictive Cardiovascular Indicator
Regulation 870.2210
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QAQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Edwards Lifesciences, LLC | 4 | 0 |
| Edwards Lifeciences, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2025 | K242518 | Hypertension Prediction Index (HePI) Algorithm Edwards Lifesciences, LLC | QAQ |
| Jun 8, 2023 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm Edwards Lifesciences, LLC | QAQ |
| Jul 30, 2021 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform Edwards Lifesciences, LLC | QAQ |
| May 21, 2019 | K183646 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advance Edwards Lifeciences, LLC | QAQ |
| Mar 16, 2018 | DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software Edwards Lifesciences, LLC | QAQ |
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