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FDA 510(k)

BLOOD FILTER, W/SET

K-Number: K771430 · 1977-09-20

ApplicantTerumo America, Inc.
Decision Date1977-09-20
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOOD FILTER, W/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 1977-09-20 under 510(k) number K771430. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD FILTER, W/SET?

BLOOD FILTER, W/SET is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is Terumo America, Inc.. The 510(k) number is K771430.

When did BLOOD FILTER, W/SET receive FDA 510(k) clearance?

BLOOD FILTER, W/SET received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771430.

Who is the listed applicant for BLOOD FILTER, W/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 BLOOD FILTER, W/SET?

The FDA product code for BLOOD FILTER, W/SET is FPB.

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Other records listing Terumo America, Inc. as applicant

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Related Devices (Code: FPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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