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FDA 510(k)

MiniGuard Arterial Safety Valve

K-Number: K182442 · 2018-11-06

ApplicantQuest Medical, Inc.
Decision Date2018-11-06
Product CodeMJJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MiniGuard Arterial Safety Valve is a medical device manufactured by Quest Medical, Inc.. It received FDA 510(k) clearance on 2018-11-06 under approval number K182442. The device is classified under product code MJJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniGuard Arterial Safety Valve?

MiniGuard Arterial Safety Valve is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Quest Medical, Inc.. The 510(k) number is K182442.

When was MiniGuard Arterial Safety Valve approved by the FDA?

MiniGuard Arterial Safety Valve received FDA 510(k) clearance on 2018-11-06, under approval number K182442.

What company makes MiniGuard Arterial Safety Valve?

MiniGuard Arterial Safety Valve is manufactured by Quest Medical, Inc..

What is the FDA product code for MiniGuard Arterial Safety Valve?

The FDA product code for MiniGuard Arterial Safety Valve is MJJ.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT04818502 Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation ACTIVE_NOT_RECRUITING NCT06777368 REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07605624 Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40278172 A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants. Journal of cardiovascular development and disease (2025)

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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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