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FDA 510(k)

THE CROSSER 14 OTW CATHETER, MODEL CRU014

K-Number: K091254 · 2009-05-29

ApplicantFlowcardia, Inc.
Decision Date2009-05-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CROSSER 14 OTW CATHETER, MODEL CRU014 is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K091254. 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 THE CROSSER 14 OTW CATHETER, MODEL CRU014?

THE CROSSER 14 OTW CATHETER, MODEL CRU014 is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Flowcardia, Inc.. The 510(k) number is K091254.

When did THE CROSSER 14 OTW CATHETER, MODEL CRU014 receive FDA 510(k) clearance?

THE CROSSER 14 OTW CATHETER, MODEL CRU014 received FDA 510(k) clearance on 2009-05-29, under 510(k) number K091254.

Who is the listed applicant for THE CROSSER 14 OTW CATHETER, MODEL CRU014?

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

What is the FDA product code for THE CROSSER 14 OTW CATHETER, MODEL CRU014?

The FDA product code for THE CROSSER 14 OTW CATHETER, MODEL CRU014 is DQY.

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Other records listing Flowcardia, Inc. as applicant

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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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