PHERESIS NEEDLE ASSEMBLY— 510(k) K810076

Name: FDA 510(k) clearance K810076
Creator: U.S. Food and Drug Administration
Published: 1981-03-05

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K810076 for PHERESIS NEEDLE ASSEMBLY, Substantially Equivalent on 1981-03-05. Applicant: Haemonetics Corp.. Device class: 1.

Clearance details

Applicant: Haemonetics Corp.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-01-13
Decision date: 1981-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.