HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable— 510(k) K223127

Clearance details

Applicant

Edwards Lifeciences, LLC

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2022-10-03

Decision date

2022-11-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Irvine, CA, US

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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 →