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FDA 510(k)

CONCENTRIC BALLOON GUIDE CATHETER

K-Number: K112404 · 2012-03-15

ApplicantConcentric Medical, Inc.
Decision Date2012-03-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC BALLOON GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical, Inc.. It received FDA 510(k) clearance on 2012-03-15 under 510(k) number K112404. 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 CONCENTRIC BALLOON GUIDE CATHETER?

CONCENTRIC BALLOON GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2012-03-15. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K112404.

When did CONCENTRIC BALLOON GUIDE CATHETER receive FDA 510(k) clearance?

CONCENTRIC BALLOON GUIDE CATHETER received FDA 510(k) clearance on 2012-03-15, under 510(k) number K112404.

Who is the listed applicant for CONCENTRIC BALLOON GUIDE CATHETER?

The FDA 510(k) record lists Concentric Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONCENTRIC BALLOON GUIDE CATHETER?

The FDA product code for CONCENTRIC BALLOON GUIDE CATHETER is DQY.

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Other records listing Concentric Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)K131437MODIFIED CONCENTRIC MICROCATHETERK131492MODIFIED FLOWGATE BALLOON GUIDE CATHETERK122581MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254K122478MODIFIED TREVO RETRIEVERK120961TREVO RETRIEVER

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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