PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER— 510(k) K884534

Name: FDA 510(k) clearance K884534
Creator: U.S. Food and Drug Administration
Published: 1989-01-24

Substantially Equivalent

Pall Biomedical Products Co.

FDA 510(k) clearance K884534 for PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER, Substantially Equivalent on 1989-01-24. Applicant: Pall Biomedical Products Co.. Device class: 2.

Clearance details

Applicant: Pall Biomedical Products Co.
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1988-10-28
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Cove, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JPA

product code JPA

Death: 6
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.