Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WILLOW/ELM PTA BALLOON DILATATION CATHETER

K-Number: K102645 · 2010-12-10

ApplicantCreagh Medical, Ltd.
Decision Date2010-12-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WILLOW/ELM PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical, Ltd.. It received FDA 510(k) clearance on 2010-12-10 under 510(k) number K102645. 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 WILLOW/ELM PTA BALLOON DILATATION CATHETER?

WILLOW/ELM PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Creagh Medical, Ltd.. The 510(k) number is K102645.

When did WILLOW/ELM PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

WILLOW/ELM PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2010-12-10, under 510(k) number K102645.

Who is the listed applicant for WILLOW/ELM PTA BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Creagh Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WILLOW/ELM PTA BALLOON DILATATION CATHETER?

The FDA product code for WILLOW/ELM PTA BALLOON DILATATION CATHETER is LIT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Creagh Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230191Arise™ UHP Dilatation CatheterK200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterK180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterK113468ELM PTA BALLON DILATATION CATHETER

Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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.

↑