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FDA 510(k)

OPTIS Metallic Stent Optimization E.4 SW

K-Number: K160878 · 2016-06-29

ApplicantLightlab Imaging, Inc.
Decision Date2016-06-29
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIS Metallic Stent Optimization E.4 SW is a medical device manufactured by Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under approval number K160878. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIS Metallic Stent Optimization E.4 SW?

OPTIS Metallic Stent Optimization E.4 SW is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Lightlab Imaging, Inc.. The 510(k) number is K160878.

When was OPTIS Metallic Stent Optimization E.4 SW approved by the FDA?

OPTIS Metallic Stent Optimization E.4 SW received FDA 510(k) clearance on 2016-06-29, under approval number K160878.

What company makes OPTIS Metallic Stent Optimization E.4 SW?

OPTIS Metallic Stent Optimization E.4 SW is manufactured by Lightlab Imaging, Inc..

What is the FDA product code for OPTIS Metallic Stent Optimization E.4 SW?

The FDA product code for OPTIS Metallic Stent Optimization E.4 SW is NQQ.

Related Clinical Trials

NCT05493904 PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) ACTIVE_NOT_RECRUITING NCT07559968 12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction NOT_YET_RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING

Related Devices (Code: NQQ)

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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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