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)

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

K-Number: K242419 · 2024-11-15

ApplicantCreagh Medical Ltd. Dba Surmodics, Inc.
Decision Date2024-11-15
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is a medical device manufactured by Creagh Medical Ltd. Dba Surmodics, Inc.. It received FDA 510(k) clearance on 2024-11-15 under approval number K242419. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Creagh Medical Ltd. Dba Surmodics, Inc.. The 510(k) number is K242419.

When was 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter approved by the FDA?

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-11-15, under approval number K242419.

What company makes 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is manufactured by Creagh Medical Ltd. Dba Surmodics, Inc..

What is the FDA product code for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

The FDA product code for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is LIT.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT05846893 Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease ACTIVE_NOT_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 NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA 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.

↑