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FDA 510(k)

MICROSHEATH LP AND LP-AT

K-Number: K080849 · 2008-07-25

ApplicantFlowcardia, Inc.
Decision Date2008-07-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICROSHEATH LP AND LP-AT is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K080849. 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 MICROSHEATH LP AND LP-AT?

MICROSHEATH LP AND LP-AT is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Flowcardia, Inc.. The 510(k) number is K080849.

When did MICROSHEATH LP AND LP-AT receive FDA 510(k) clearance?

MICROSHEATH LP AND LP-AT received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080849.

Who is the listed applicant for MICROSHEATH LP AND LP-AT?

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 MICROSHEATH LP AND LP-AT?

The FDA product code for MICROSHEATH LP AND LP-AT 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.

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Other records listing Flowcardia, 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.

K092175THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100K091254THE CROSSER 14 OTW CATHETER, MODEL CRU014K091119MODIFICATION TO THE CROSSER SYSTEMK080765CROSSER LP SYSTEMK073289MICROSHEATH XL CATHETERS

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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, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT 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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