HAEMOCELL SYSTEM 350 OR S350— 510(k) K960734

Name: FDA 510(k) clearance K960734
Creator: U.S. Food and Drug Administration
Published: 1996-12-10

Substantially Equivalent

Haemocell Plc

FDA 510(k) clearance K960734 for HAEMOCELL SYSTEM 350 OR S350, Substantially Equivalent on 1996-12-10. Applicant: Haemocell Plc. Device class: 2.

Clearance details

Applicant: Haemocell Plc
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1996-02-22
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abingdon, Oxon, England, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.