DeviceClearance

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module— 510(k) K201446

Substantially Equivalent

Edwards Lifesiences, LLC

FDA 510(k) clearance K201446 for HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module, Substantially Equivalent on 2020-10-01. Applicant: Edwards Lifesiences, LLC. Device class: 2.

Clearance details

Applicant
Edwards Lifesiences, 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 →

Recalls naming K201446

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201446.

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