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)

Houdini Cross Support Catheter

K-Number: K213466 · 2022-10-20

ApplicantCruzar Medsystems, Inc.
Decision Date2022-10-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Houdini Cross Support Catheter is a medical device manufactured by Cruzar Medsystems, Inc.. It received FDA 510(k) clearance on 2022-10-20 under approval number K213466. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Houdini Cross Support Catheter?

Houdini Cross Support Catheter is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Cruzar Medsystems, Inc.. The 510(k) number is K213466.

When was Houdini Cross Support Catheter approved by the FDA?

Houdini Cross Support Catheter received FDA 510(k) clearance on 2022-10-20, under approval number K213466.

What company makes Houdini Cross Support Catheter?

Houdini Cross Support Catheter is manufactured by Cruzar Medsystems, Inc..

What is the FDA product code for Houdini Cross Support Catheter?

The FDA product code for Houdini Cross Support Catheter is DQY.

Related Clinical Trials

NCT03590327 Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment COMPLETED NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT04821453 NAVA vs. CMV Crossover in Severe BPD TERMINATED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT06945952 Efficacy of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Prediction of Successful Weaning ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41945713 Strength of Evidence to Support Decision-Making on the Use of Digital Mental Health Technologies in NICE Evaluations: Cross-Sectional Analysis of Studies. JMIR mental health (2026)

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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.

↑