FDA 510(k)

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY

K-Number: K001423 · 2000-07-21

ApplicantKawasumi Laboratories America, Inc.

Decision Date2000-07-21

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories America, Inc.. It received FDA 510(k) clearance on 2000-07-21 under 510(k) number K001423. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY?

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Kawasumi Laboratories America, Inc.. The 510(k) number is K001423.

When did KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY receive FDA 510(k) clearance?

KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY received FDA 510(k) clearance on 2000-07-21, under 510(k) number K001423.

Who is the listed applicant for KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY?

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

What is the FDA product code for KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY?

The FDA product code for KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY is FPA.

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Other records listing Kawasumi Laboratories America, Inc. as applicant

K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD K001043KAWASUMI LABORATORY BLOOD DRAWING KIT

Related Devices (Code: FPA)

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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.