WebInari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs & Quality Assurance 9272 Jeronimo Road, Suite 124 Irvine, CA 92618 Re: K162970 Trade/Device Name: FlowTriever Retrieval/Aspiration System ... • FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm) WebCompany Name: INARI MEDICAL INC Primary DI Number: 00850291007147 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: ClotTriever Catheter, 16 mm, 115 cm, Variable ClotTriever - Device Characteristics ClotTriever - GMDN ClotTriever - Sterilization Device Packaged as Sterile: True
Inari Medical wins FDA nod for ClotTriever peripheral thrombectomy …
WebApr 10, 2024 · Last year Inari won an investigational device exemption from the FDA for a clinical trial of the FlowTriever device, the 150-patient Flare study, with a primary safety endpoint of major adverse ... WebNov 3, 2024 · For patients with intermediate- or high-risk pulmonary embolism (PE), removing the blockage with the FlowTriever percutaneous mechanical thrombectomy system (Inari Medical) is both safe and effective, according to an expanded interim analysis of the FLASH registry. The procedure provided immediate hemodynamic benefits while … how does aetherflux reservoir work
FlowTriever System for mechanical thromboembolectomy
WebDec 3, 2024 · To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. ... Inari Medical ... WebJan 8, 2024 · January 8, 2024—Inari Medical announced FDA 510(k) clearance of the company’s FlowTriever system for the treatment of clot in transit (CIT) in the right atrium. The FlowTriever thrombectomy system does not require a cardiopulmonary bypass circuit. WebThe Inari ClotTriever system (Inari Medical Inc., CA, USA) is a thrombectomy device, which is approved for deep vein thrombosis by the US FDA in 2024. Herein we review the current treatment... how does aeroplan ship gift cards