TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge— 510(k) K251024

Substantially Equivalent

Haemonetics

FDA 510(k) clearance K251024 for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge, Substantially Equivalent on 2025-04-30. Applicant: Haemonetics.

Clearance details

Applicant: Haemonetics
Product code: Code JPA
Advisory panel: Hematology
Date received: 2025-04-02
Decision date: 2025-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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.