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FDA 510(k)

X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR

K-Number: K993772 · 2000-06-05

ApplicantTerumo Medical Corp.
Decision Date2000-06-05
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR 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 2000-06-05 under 510(k) number K993772. 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 X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR?

X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Terumo Medical Corp.. The 510(k) number is K993772.

When did X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR receive FDA 510(k) clearance?

X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR received FDA 510(k) clearance on 2000-06-05, under 510(k) number K993772.

Who is the listed applicant for X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR?

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 X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR?

The FDA product code for X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR is 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.

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