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FDA 510(k)

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118

K-Number: K041410 · 2004-07-28

ApplicantIcu Medical, Inc.
Decision Date2004-07-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2004-07-28 under 510(k) number K041410. 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 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118?

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Icu Medical, Inc.. The 510(k) number is K041410.

When did PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 receive FDA 510(k) clearance?

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041410.

Who is the listed applicant for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118?

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

What is the FDA product code for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118?

The FDA product code for PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 is FPA.

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Related Devices (Code: FPA)

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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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