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FDA 510(k)

Arise™ UHP Dilatation Catheter

K-Number: K230191 · 2023-03-22

ApplicantCreagh Medical, Ltd.
Decision Date2023-03-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arise™ UHP 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 2023-03-22 under 510(k) number K230191. 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 Arise™ UHP Dilatation Catheter?

Arise™ UHP Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Creagh Medical, Ltd.. The 510(k) number is K230191.

When did Arise™ UHP Dilatation Catheter receive FDA 510(k) clearance?

Arise™ UHP Dilatation Catheter received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230191.

Who is the listed applicant for Arise™ UHP 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 Arise™ UHP Dilatation Catheter?

The FDA product code for Arise™ UHP Dilatation Catheter is LIT.

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.

K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterK180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterK171251014 Hydrophilic Coated PTA Balloon 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.

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

View on FDA Database →

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

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