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FDA 510(k)

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR

K-Number: K030449 · 2003-03-05

ApplicantTerumo Corp.
Decision Date2003-03-05
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2003-03-05 under 510(k) number K030449. 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 MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR?

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR is a medical device that received FDA 510(k) clearance on 2003-03-05. The listed applicant is Terumo Corp.. The 510(k) number is K030449.

When did MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR receive FDA 510(k) clearance?

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR received FDA 510(k) clearance on 2003-03-05, under 510(k) number K030449.

Who is the listed applicant for MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR?

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

What is the FDA product code for MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR?

The FDA product code for MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR is DTN.

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Other records listing Terumo Corp. as applicant

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Related Devices (Code: 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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