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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 the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) 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. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K160878.

When did OPTIS Metallic Stent Optimization E.4 SW receive FDA 510(k) clearance?

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

Who is the listed applicant for OPTIS Metallic Stent Optimization E.4 SW?

The FDA 510(k) record lists Lightlab Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: NQQ)

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.

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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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