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FDA 510(k)

ViziShot FLEX

K-Number: K152922 · 2016-02-19

ApplicantSpiration, Inc.
Decision Date2016-02-19
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ViziShot FLEX is a medical device manufactured by Spiration, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K152922. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViziShot FLEX?

ViziShot FLEX is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Spiration, Inc.. The 510(k) number is K152922.

When was ViziShot FLEX approved by the FDA?

ViziShot FLEX received FDA 510(k) clearance on 2016-02-19, under approval number K152922.

What company makes ViziShot FLEX?

ViziShot FLEX is manufactured by Spiration, Inc..

What is the FDA product code for ViziShot FLEX?

The FDA product code for ViziShot FLEX is KTI.

Other Devices by Spiration, Inc.

K171492B7 2C Occlusion Balloon K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator K162611PeriFLEX

Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC K171232PeriView FLEXOlympus Surgical Technologies America K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation K163469ViziShot 2 FLEXOlympus Surgical Technologies America K181193PeriView FLEXOlympus Surgical Technologies America

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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