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FDA 510(k)

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

K-Number: K180007 · 2018-04-19

ApplicantCreagh Medical, Ltd.
Decision Date2018-04-19
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.. It received FDA 510(k) clearance on 2018-04-19 under approval number K180007. 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 2018-04-19. It is manufactured by Creagh Medical, Ltd.. The 510(k) number is K180007.

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 2018-04-19, under approval number K180007.

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..

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

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Other Devices by Creagh Medical, Ltd.

K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter K230191Arise™ UHP Dilatation Catheter

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

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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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