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FDA 510(k)

CAPIOX SX HARDSHELL RESEVOIR

K-Number: K982223 · 1998-09-10

ApplicantTerumo Medical Corp.
Decision Date1998-09-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX SX HARDSHELL RESEVOIR 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 1998-09-10 under 510(k) number K982223. 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 SX HARDSHELL RESEVOIR?

CAPIOX SX HARDSHELL RESEVOIR is a medical device that received FDA 510(k) clearance on 1998-09-10. The listed applicant is Terumo Medical Corp.. The 510(k) number is K982223.

When did CAPIOX SX HARDSHELL RESEVOIR receive FDA 510(k) clearance?

CAPIOX SX HARDSHELL RESEVOIR received FDA 510(k) clearance on 1998-09-10, under 510(k) number K982223.

Who is the listed applicant for CAPIOX SX HARDSHELL RESEVOIR?

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 SX HARDSHELL RESEVOIR?

The FDA product code for CAPIOX SX HARDSHELL RESEVOIR is DTN.

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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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