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FDA 510(k)

CAPIOX HARDSHELL VENOUS RESERVOIR

K-Number: K894664 · 1990-04-20

ApplicantTerumo Medical Corp.
Decision Date1990-04-20
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX HARDSHELL VENOUS 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 1990-04-20 under 510(k) number K894664. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX HARDSHELL VENOUS RESERVOIR?

CAPIOX HARDSHELL VENOUS RESERVOIR is a medical device that received FDA 510(k) clearance on 1990-04-20. The listed applicant is Terumo Medical Corp.. The 510(k) number is K894664.

When did CAPIOX HARDSHELL VENOUS RESERVOIR receive FDA 510(k) clearance?

CAPIOX HARDSHELL VENOUS RESERVOIR received FDA 510(k) clearance on 1990-04-20, under 510(k) number K894664.

Who is the listed applicant for CAPIOX HARDSHELL VENOUS 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 CAPIOX HARDSHELL VENOUS RESERVOIR?

The FDA product code for CAPIOX HARDSHELL VENOUS RESERVOIR is DTN.

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Other records listing Terumo Medical 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.

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