FDA 510(k)

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100

K-Number: K090621 · 2009-06-19

Decision Date2009-06-19

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2009-06-19 under 510(k) number K090621. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100?

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 is a medical device that received FDA 510(k) clearance on 2009-06-19. The listed applicant is Flowcardia, Inc.. The 510(k) number is K090621.

When did FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 receive FDA 510(k) clearance?

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 received FDA 510(k) clearance on 2009-06-19, under 510(k) number K090621.

Who is the listed applicant for FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100?

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 FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100?

The FDA product code for FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.