DeviceClearance

HemoSphere Alta Advanced Monitoring Platform +3 more— 510(k) K232294

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K232294 for HemoSphere Alta Advanced Monitoring Platform +3 more, Substantially Equivalent on 2023-10-31. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Device name as filed
HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
Applicant
Edwards Lifesciences, LLC
Product code
Code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.