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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 the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2018-08-30 under 510(k) 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. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K182024.

When did Dissecting Balloon System receive FDA 510(k) clearance?

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

Who is the listed applicant for Dissecting Balloon System?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dissecting Balloon System?

The FDA product code for Dissecting Balloon System is GCJ.

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Related Devices (Code: GCJ)

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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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