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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 the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical Ltd. Dba Surmodics, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) 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. The listed applicant is Creagh Medical Ltd. Dba Surmodics, Inc.. The 510(k) number is K242419.

When did 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

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

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

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.

NCT02460042Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)COMPLETEDNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialRECRUITINGNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT03791970Stents Post-dilation With DCB or POBA in Femoropopliteal ArteriesRECRUITINGNCT04058990Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)COMPLETED

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.

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.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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