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FDA 510(k)

Dissecting Balloon System

K-Number: K182024 · 2018-08-30

ApplicantApplied Medical Resources Corp.
Decision Date2018-08-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dissecting Balloon System is a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2018-08-30 under approval number K182024. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dissecting Balloon System?

Dissecting Balloon System is a medical device that received FDA 510(k) clearance on 2018-08-30. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K182024.

When was Dissecting Balloon System approved by the FDA?

Dissecting Balloon System received FDA 510(k) clearance on 2018-08-30, under approval number K182024.

What company makes Dissecting Balloon System?

Dissecting Balloon System is manufactured by Applied Medical Resources Corp..

What is the FDA product code for Dissecting Balloon System?

The FDA product code for Dissecting Balloon System is GCJ.

Related Clinical Trials

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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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