HEMOSORB— 510(k) K021581

Name: FDA 510(k) clearance K021581
Creator: U.S. Food and Drug Administration
Published: 2002-07-12

Substantially Equivalent

On Site Gas Systems, Inc.

FDA 510(k) clearance K021581 for HEMOSORB, Substantially Equivalent on 2002-07-12. Applicant: On Site Gas Systems, Inc.. Device class: Unclassified.

Clearance details

Applicant: On Site Gas Systems, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2002-05-14
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newington, CT, US

Download summary PDF View on FDA.gov ↗

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K030920 — POGS 332004-03-10
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Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.