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FDA 510(k)

MODIFIED FLOWGATE BALLOON GUIDE CATHETER

K-Number: K131492 · 2013-10-03

ApplicantConcentric Medical, Inc.
Decision Date2013-10-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED FLOWGATE 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 2013-10-03 under 510(k) number K131492. 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 MODIFIED FLOWGATE BALLOON GUIDE CATHETER?

MODIFIED FLOWGATE BALLOON GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K131492.

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

MODIFIED FLOWGATE BALLOON GUIDE CATHETER received FDA 510(k) clearance on 2013-10-03, under 510(k) number K131492.

Who is the listed applicant for MODIFIED FLOWGATE 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 MODIFIED FLOWGATE BALLOON GUIDE CATHETER?

The FDA product code for MODIFIED FLOWGATE 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 MICROCATHETERK122581MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254K122478MODIFIED TREVO RETRIEVERK120961TREVO RETRIEVERK112404CONCENTRIC BALLOON GUIDE CATHETER

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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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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