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)

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

K-Number: K213089 · 2021-11-10

ApplicantIvenix, Inc.
Decision Date2021-11-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is a medical device manufactured by Ivenix, Inc.. It received FDA 510(k) clearance on 2021-11-10 under approval number K213089. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Ivenix, Inc.. The 510(k) number is K213089.

When was Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector approved by the FDA?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector received FDA 510(k) clearance on 2021-11-10, under approval number K213089.

What company makes Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is manufactured by Ivenix, Inc..

What is the FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

The FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is FPA.

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 NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_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 NCT05665998 Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation RECRUITING

Other Devices by Ivenix, Inc.

K183311Ivenix Infusion System (IIS)

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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.

↑