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FDA 510(k)

TERUFUSION BLOOD ADMIN. SET

K-Number: K771209 · 1977-07-26

ApplicantTerumo America, Inc.
Decision Date1977-07-26
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUFUSION BLOOD ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1977-07-26 under 510(k) number K771209. 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 TERUFUSION BLOOD ADMIN. SET?

TERUFUSION BLOOD ADMIN. SET is a medical device that received FDA 510(k) clearance on 1977-07-26. The listed applicant is Terumo America, Inc.. The 510(k) number is K771209.

When did TERUFUSION BLOOD ADMIN. SET receive FDA 510(k) clearance?

TERUFUSION BLOOD ADMIN. SET received FDA 510(k) clearance on 1977-07-26, under 510(k) number K771209.

Who is the listed applicant for TERUFUSION BLOOD ADMIN. SET?

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

What is the FDA product code for TERUFUSION BLOOD ADMIN. SET?

The FDA product code for TERUFUSION BLOOD ADMIN. SET is FMI.

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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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