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)

Single-use Balloon Dilatation Catheter

K-Number: K241888 · 2024-12-20

ApplicantLeo Medical Co., Ltd.
Decision Date2024-12-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Balloon Dilatation Catheter is a medical device manufactured by Leo Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-12-20 under approval number K241888. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-use Balloon Dilatation Catheter?

Single-use Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Leo Medical Co., Ltd.. The 510(k) number is K241888.

When was Single-use Balloon Dilatation Catheter approved by the FDA?

Single-use Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-12-20, under approval number K241888.

What company makes Single-use Balloon Dilatation Catheter?

Single-use Balloon Dilatation Catheter is manufactured by Leo Medical Co., Ltd..

What is the FDA product code for Single-use Balloon Dilatation Catheter?

The FDA product code for Single-use Balloon Dilatation Catheter is FGE.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING 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 NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING

Other Devices by Leo Medical Co., Ltd.

K172985Ligation Device

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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.

↑