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FDA 510(k)

TEG 6s Hemostasis System

K-Number: K160502 · 2017-04-19

ApplicantHaemonetics Corporation
Decision Date2017-04-19
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TEG 6s Hemostasis System is a medical device manufactured by Haemonetics Corporation. It received FDA 510(k) clearance on 2017-04-19 under approval number K160502. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEG 6s Hemostasis System?

TEG 6s Hemostasis System is a medical device that received FDA 510(k) clearance on 2017-04-19. It is manufactured by Haemonetics Corporation. The 510(k) number is K160502.

When was TEG 6s Hemostasis System approved by the FDA?

TEG 6s Hemostasis System received FDA 510(k) clearance on 2017-04-19, under approval number K160502.

What company makes TEG 6s Hemostasis System?

TEG 6s Hemostasis System is manufactured by Haemonetics Corporation.

What is the FDA product code for TEG 6s Hemostasis System?

The FDA product code for TEG 6s Hemostasis System is JPA.

Related Clinical Trials

NCT06328647 Quantra Point-of-Care Hemostasis Monitoring ACTIVE_NOT_RECRUITING NCT07495137 The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection NOT_YET_RECRUITING

Other Devices by Haemonetics Corporation

K160197Haemonetics Cell Saver Elite Autotransfusion System K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) K232018Citrated: K, KH, RTH, FFH K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

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Related Devices (Code: JPA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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