PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS— 510(k) K954202

Substantially Equivalent

Medtronic Hemotec, Inc.

FDA 510(k) clearance K954202 for PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS, Substantially Equivalent on 1996-06-20. Applicant: Medtronic Hemotec, Inc..

Clearance details

Applicant: Medtronic Hemotec, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1995-09-07
Decision date: 1996-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

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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.