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FDA 510(k)

X-SIZER CATHETER SYSTEM

K-Number: K021096 · 2004-09-08

ApplicantEv3 Corporation
Decision Date2004-09-08
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

X-SIZER CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Corporation. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K021096. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-SIZER CATHETER SYSTEM?

X-SIZER CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Ev3 Corporation. The 510(k) number is K021096.

When did X-SIZER CATHETER SYSTEM receive FDA 510(k) clearance?

X-SIZER CATHETER SYSTEM received FDA 510(k) clearance on 2004-09-08, under 510(k) number K021096.

Who is the listed applicant for X-SIZER CATHETER SYSTEM?

The FDA 510(k) record lists Ev3 Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-SIZER CATHETER SYSTEM?

The FDA product code for X-SIZER CATHETER SYSTEM is MCW.

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Other records listing Ev3 Corporation as applicant

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Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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