Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01

K-Number: K191364 · 2020-02-14

ApplicantFujimori Kogyo, Co., Ltd.
Decision Date2020-02-14
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 is a medical device manufactured by Fujimori Kogyo, Co., Ltd.. It received FDA 510(k) clearance on 2020-02-14 under approval number K191364. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01?

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Fujimori Kogyo, Co., Ltd.. The 510(k) number is K191364.

When was T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 approved by the FDA?

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 received FDA 510(k) clearance on 2020-02-14, under approval number K191364.

What company makes T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01?

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 is manufactured by Fujimori Kogyo, Co., Ltd..

What is the FDA product code for T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01?

The FDA product code for T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 is JOZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING

Related PubMed Literature

PMID: 41938148 Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025). Endoscopic ultrasound (2026) PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37306642 Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union. Neuromodulation : journal of the International Neuromodulation Society (2024)

Related Devices (Code: JOZ)

K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. K181777AggreGuide A-100 ADPAggredyne, Inc.

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.

↑