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FDA 510(k)

8F FlowGate2 Balloon Guide Catheter

K-Number: K153729 · 2016-01-27

ApplicantConcentric Medical
Decision Date2016-01-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8F FlowGate2 Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K153729. 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 8F FlowGate2 Balloon Guide Catheter?

8F FlowGate2 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Concentric Medical. The 510(k) number is K153729.

When did 8F FlowGate2 Balloon Guide Catheter receive FDA 510(k) clearance?

8F FlowGate2 Balloon Guide Catheter received FDA 510(k) clearance on 2016-01-27, under 510(k) number K153729.

Who is the listed applicant for 8F FlowGate2 Balloon Guide Catheter?

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

What is the FDA product code for 8F FlowGate2 Balloon Guide Catheter?

The FDA product code for 8F FlowGate2 Balloon Guide Catheter is DQY.

Related Clinical Trials

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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Concentric Medical 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)

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.

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 CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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