FDA 510(k)

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT

K-Number: K071998 · 2007-09-26

Decision Date2007-09-26

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2007-09-26 under 510(k) number K071998. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT?

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT is a medical device that received FDA 510(k) clearance on 2007-09-26. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K071998.

When did ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT receive FDA 510(k) clearance?

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT received FDA 510(k) clearance on 2007-09-26, under 510(k) number K071998.

Who is the listed applicant for ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT?

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

What is the FDA product code for ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT?

The FDA product code for ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT is FMI.

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Other records listing Arrow Intl., Inc. as applicant

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Related Devices (Code: FMI)

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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.