FDA 510(k)

CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR

K-Number: K062381 · 2006-08-24

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2006-08-24

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2006-08-24 under 510(k) number K062381. 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 CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR?

CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR is a medical device that received FDA 510(k) clearance on 2006-08-24. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K062381.

When did CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR receive FDA 510(k) clearance?

CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR received FDA 510(k) clearance on 2006-08-24, under 510(k) number K062381.

Who is the listed applicant for CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR?

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

What is the FDA product code for CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR?

The FDA product code for CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR is DTZ.

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Other records listing Terumo Cardiovascular Systems Corp. as applicant

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Related Devices (Code: DTZ)

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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.