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FDA 510(k)

Imager II Urology Torque Catheter

K-Number: K180530 · 2018-04-10

ApplicantBoston Scientific Corporation
Decision Date2018-04-10
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Imager II Urology Torque Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-04-10 under approval number K180530. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imager II Urology Torque Catheter?

Imager II Urology Torque Catheter is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Boston Scientific Corporation. The 510(k) number is K180530.

When was Imager II Urology Torque Catheter approved by the FDA?

Imager II Urology Torque Catheter received FDA 510(k) clearance on 2018-04-10, under approval number K180530.

What company makes Imager II Urology Torque Catheter?

Imager II Urology Torque Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Imager II Urology Torque Catheter?

The FDA product code for Imager II Urology Torque Catheter is KOD.

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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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