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)

Radical the Dude 8F Guide Catheter

K-Number: K243577 · 2025-01-14

ApplicantMaduro Medical, Inc.
Decision Date2025-01-14
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radical the Dude 8F Guide Catheter is a medical device manufactured by Maduro Medical, Inc.. It received FDA 510(k) clearance on 2025-01-14 under approval number K243577. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radical the Dude 8F Guide Catheter?

Radical the Dude 8F Guide Catheter is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Maduro Medical, Inc.. The 510(k) number is K243577.

When was Radical the Dude 8F Guide Catheter approved by the FDA?

Radical the Dude 8F Guide Catheter received FDA 510(k) clearance on 2025-01-14, under approval number K243577.

What company makes Radical the Dude 8F Guide Catheter?

Radical the Dude 8F Guide Catheter is manufactured by Maduro Medical, Inc..

What is the FDA product code for Radical the Dude 8F Guide Catheter?

The FDA product code for Radical the Dude 8F Guide Catheter is QJP.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07576790 Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT) NOT_YET_RECRUITING

Other Devices by Maduro Medical, Inc.

K231393Radical the Dude 7F Guide Catheter K253975Radical 6F Access Catheter

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, 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.

↑