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FDA 510(k)

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR

K-Number: K130520 · 2013-03-13

ApplicantAshitaka Factory of Terumo Corp.
Decision Date2013-03-13
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Corp.. It received FDA 510(k) clearance on 2013-03-13 under 510(k) number K130520. 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 FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR?

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR is a medical device that received FDA 510(k) clearance on 2013-03-13. The listed applicant is Ashitaka Factory of Terumo Corp.. The 510(k) number is K130520.

When did CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR receive FDA 510(k) clearance?

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR received FDA 510(k) clearance on 2013-03-13, under 510(k) number K130520.

Who is the listed applicant for CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR?

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

What is the FDA product code for CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR?

The FDA product code for CAPIOX FX15 AND FX25 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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