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FDA 510(k)

TRAILBLAZER SUPPORT CATHETER

K-Number: K092299 · 2009-08-07

ApplicantEv3, Inc.
Decision Date2009-08-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAILBLAZER SUPPORT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K092299. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAILBLAZER SUPPORT CATHETER?

TRAILBLAZER SUPPORT CATHETER is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Ev3, Inc.. The 510(k) number is K092299.

When did TRAILBLAZER SUPPORT CATHETER receive FDA 510(k) clearance?

TRAILBLAZER SUPPORT CATHETER received FDA 510(k) clearance on 2009-08-07, under 510(k) number K092299.

Who is the listed applicant for TRAILBLAZER SUPPORT CATHETER?

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

What is the FDA product code for TRAILBLAZER SUPPORT CATHETER?

The FDA product code for TRAILBLAZER SUPPORT CATHETER is DQY.

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Other records listing Ev3, Inc. as applicant

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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Related Devices (Code: DQY)

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

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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