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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 a medical device manufactured by Contego Medical, LLC. It received FDA 510(k) clearance on 2018-09-06 under approval 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. It is manufactured by Contego Medical, LLC. The 510(k) number is K181128.

When was Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) approved by the FDA?

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

What company makes 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 manufactured by Contego Medical, LLC.

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

NCT06027788 CTSN Embolic Protection Trial RECRUITING NCT07195708 Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') NOT_YET_RECRUITING NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Contego Medical, LLC

K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

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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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