FDA 510(k)

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

K-Number: K051997 · 2005-09-15

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2005-09-15

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL 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 2005-09-15 under 510(k) number K051997. 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 RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR?

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR is a medical device that received FDA 510(k) clearance on 2005-09-15. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K051997.

When did CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR receive FDA 510(k) clearance?

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR received FDA 510(k) clearance on 2005-09-15, under 510(k) number K051997.

Who is the listed applicant for CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL 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 RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR?

The FDA product code for CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR is DTZ.

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Other records listing Terumo Cardiovascular Systems 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.