TEG 6s Hemostasis System— 510(k) K160502

Name: FDA 510(k) clearance K160502
Creator: U.S. Food and Drug Administration
Published: 2017-04-19

Substantially Equivalent

Haemonetics Corporation

FDA 510(k) clearance K160502 for TEG 6s Hemostasis System, Substantially Equivalent on 2017-04-19. Applicant: Haemonetics Corporation. Device class: 2.

Clearance details

Applicant: Haemonetics Corporation
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2016-02-23
Decision date: 2017-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2025-04-30
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K232018 — Citrated: K, KH, RTH, FFH2024-03-29

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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.