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FDA 510(k)

TERUMO HOLLOW OXYGENATOR CIRCUIT

K-Number: K812659 · 1981-12-14

ApplicantTerumo Medical Corp.
Decision Date1981-12-14
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO HOLLOW OXYGENATOR CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K812659. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO HOLLOW OXYGENATOR CIRCUIT?

TERUMO HOLLOW OXYGENATOR CIRCUIT is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Terumo Medical Corp.. The 510(k) number is K812659.

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

TERUMO HOLLOW OXYGENATOR CIRCUIT received FDA 510(k) clearance on 1981-12-14, under 510(k) number K812659.

Who is the listed applicant for TERUMO HOLLOW OXYGENATOR CIRCUIT?

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

What is the FDA product code for TERUMO HOLLOW OXYGENATOR CIRCUIT?

The FDA product code for TERUMO HOLLOW OXYGENATOR CIRCUIT is DTM.

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Other records listing Terumo Medical Corp. as applicant

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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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