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FDA 510(k)

ELM PTA BALLON DILATATION CATHETER

K-Number: K113468 · 2011-12-20

ApplicantCreagh Medical, Ltd.
Decision Date2011-12-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELM PTA BALLON 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 2011-12-20 under 510(k) number K113468. 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 ELM PTA BALLON DILATATION CATHETER?

ELM PTA BALLON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Creagh Medical, Ltd.. The 510(k) number is K113468.

When did ELM PTA BALLON DILATATION CATHETER receive FDA 510(k) clearance?

ELM PTA BALLON DILATATION CATHETER received FDA 510(k) clearance on 2011-12-20, under 510(k) number K113468.

Who is the listed applicant for ELM PTA BALLON 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 ELM PTA BALLON DILATATION CATHETER?

The FDA product code for ELM PTA BALLON 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.

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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 CatheterK102645WILLOW/ELM 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.

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

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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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