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FDA 510(k)

TERUMO HOLLOW FIBER OXYGENATOR

K-Number: K802970 · 1981-01-22

ApplicantTerumo America, Inc.
Decision Date1981-01-22
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO HOLLOW FIBER OXYGENATOR 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 1981-01-22 under 510(k) number K802970. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO HOLLOW FIBER OXYGENATOR?

TERUMO HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 1981-01-22. The listed applicant is Terumo America, Inc.. The 510(k) number is K802970.

When did TERUMO HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

TERUMO HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 1981-01-22, under 510(k) number K802970.

Who is the listed applicant for TERUMO HOLLOW FIBER OXYGENATOR?

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 TERUMO HOLLOW FIBER OXYGENATOR?

The FDA product code for TERUMO HOLLOW FIBER OXYGENATOR is DTZ.

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Other records listing Terumo America, Inc. as applicant

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K811523PLASMA FLEXK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZERK801192CLIRANS TE10 HOLLOW FIBER DIALYZER

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Related Devices (Code: DTZ)

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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