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FDA 510(k)

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

K-Number: K163314 · 2017-03-23

ApplicantBoston Scientific Corporation
Decision Date2017-03-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-03-23 under approval number K163314. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter?

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter is a medical device that received FDA 510(k) clearance on 2017-03-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K163314.

When was Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter approved by the FDA?

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter received FDA 510(k) clearance on 2017-03-23, under approval number K163314.

What company makes Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter?

Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter?

The FDA product code for Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter is DQY.

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Related Devices (Code: DQY)

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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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