FDA 510(k)

CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X

K-Number: K011804 · 2001-07-09

ApplicantTerumo Cardiovascular Systems Corp.

Decision Date2001-07-09

Product CodeDTM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X 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 2001-07-09 under 510(k) number K011804. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X?

CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K011804.

When did CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X receive FDA 510(k) clearance?

CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011804.

Who is the listed applicant for CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X?

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 ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X?

The FDA product code for CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X is DTM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.