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FDA 510(k)

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR

K-Number: K130493 · 2013-03-13

ApplicantTerumo Corporation
Decision Date2013-03-13
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2013-03-13 under 510(k) number K130493. 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 RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR?

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR is a medical device that received FDA 510(k) clearance on 2013-03-13. The listed applicant is Terumo Corporation. The 510(k) number is K130493.

When did CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR receive FDA 510(k) clearance?

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR received FDA 510(k) clearance on 2013-03-13, under 510(k) number K130493.

Who is the listed applicant for CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR?

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

What is the FDA product code for CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR?

The FDA product code for CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR is DTZ.

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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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