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FDA 510(k)

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

K-Number: K181128 · 2018-09-06

ApplicantContego Medical, LLC
Decision Date2018-09-06
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, LLC. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K181128. 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 Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Contego Medical, LLC. The 510(k) number is K181128.

When did Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) receive FDA 510(k) clearance?

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) received FDA 510(k) clearance on 2018-09-06, under 510(k) number K181128.

Who is the listed applicant for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

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

What is the FDA product code for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)?

The FDA product code for Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is LIT.

Related Clinical Trials

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Other records listing Contego Medical, LLC 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.

PMA P240009Stent, carotidK251485Excipio LV Prime Thrombectomy DeviceK230030Excipio SV Aspiration Catheter and TubingK223897Excipio LV Thrombectomy DeviceK221204Excipio SV Thrombectomy DeviceK221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

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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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