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FDA 510(k)

Ivenix Infusion System (IIS)

K-Number: K183311 · 2019-06-07

ApplicantIvenix, Inc.
Decision Date2019-06-07
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ivenix Infusion System (IIS) is a medical device manufactured by Ivenix, Inc.. It received FDA 510(k) clearance on 2019-06-07 under approval number K183311. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ivenix Infusion System (IIS)?

Ivenix Infusion System (IIS) is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Ivenix, Inc.. The 510(k) number is K183311.

When was Ivenix Infusion System (IIS) approved by the FDA?

Ivenix Infusion System (IIS) received FDA 510(k) clearance on 2019-06-07, under approval number K183311.

What company makes Ivenix Infusion System (IIS)?

Ivenix Infusion System (IIS) is manufactured by Ivenix, Inc..

What is the FDA product code for Ivenix Infusion System (IIS)?

The FDA product code for Ivenix Infusion System (IIS) is FRN.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED NCT01384513 A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies COMPLETED

Other Devices by Ivenix, Inc.

K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

Related Devices (Code: FRN)

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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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