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)

MAGIC Infusion Catheter

K-Number: K202366 · 2021-01-29

ApplicantBalt USA, LLC
Decision Date2021-01-29
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGIC Infusion Catheter is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2021-01-29 under approval number K202366. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGIC Infusion Catheter?

MAGIC Infusion Catheter is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Balt USA, LLC. The 510(k) number is K202366.

When was MAGIC Infusion Catheter approved by the FDA?

MAGIC Infusion Catheter received FDA 510(k) clearance on 2021-01-29, under approval number K202366.

What company makes MAGIC Infusion Catheter?

MAGIC Infusion Catheter is manufactured by Balt USA, LLC.

What is the FDA product code for MAGIC Infusion Catheter?

The FDA product code for MAGIC Infusion Catheter is KRA.

Related Clinical Trials

NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention 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 NCT03065335 Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder RECRUITING

Other Devices by Balt USA, LLC

K182337HYBRID Guidewire K183045Eclipse 2L K182918Ballast 088 Long Sheath K200030Optima Coil System K223386Optima Coil System K213435MAGIC Flow-Dependent Microcatheter

View all 19 devices →

Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, 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.

↑