HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform— 510(k) K211465

Substantially Equivalent

Edwards Lfesciences

FDA 510(k) clearance K211465 for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform, Substantially Equivalent on 2021-07-08. Applicant: Edwards Lfesciences.

Clearance details

Applicant: Edwards Lfesciences
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2021-05-11
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.