FDA 510(k)

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

K-Number: K181529 · 2018-12-06

Decision Date2018-12-06

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is a medical device manufactured by Contego Medical, LLC. It received FDA 510(k) clearance on 2018-12-06 under approval number K181529. 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 Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Contego Medical, LLC. The 510(k) number is K181529.

When was Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection approved by the FDA?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection received FDA 510(k) clearance on 2018-12-06, under approval number K181529.

What company makes Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is manufactured by Contego Medical, LLC.

What is the FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection?

The FDA product code for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is LIT.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Contego Medical, LLC

K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

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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.