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FDA 510(k)

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

K-Number: K221339 · 2022-06-09

ApplicantContego Medical, Inc.
Decision Date2022-06-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K221339. 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 Carotid Post-Dilation Balloon System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Contego Medical, Inc.. The 510(k) number is K221339.

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

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection received FDA 510(k) clearance on 2022-06-09, under 510(k) number K221339.

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

The FDA 510(k) record lists Contego Medical, Inc. 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?

The FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection 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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT03892824Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral AnticoagulantsACTIVE_NOT_RECRUITING

Other records listing Contego Medical, Inc. 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 DeviceK181529Vanguard IEP Peripheral Balloon Angioplasty 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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