HEPTRAC ELECTRONIC QUALITY CONTROL— 510(k) K981815

Substantially Equivalent

Medtronic Blood Management

FDA 510(k) clearance K981815 for HEPTRAC ELECTRONIC QUALITY CONTROL, Substantially Equivalent on 1998-07-30. Applicant: Medtronic Blood Management.

Clearance details

Applicant: Medtronic Blood Management
Product code: Code JPA
Advisory panel: Hematology
Date received: 1998-05-22
Decision date: 1998-07-30
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.