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FDA 510(k)

TrailBlazer Angled Support Catheter

K-Number: K162384 · 2016-09-22

ApplicantMedtronic Vascular, Inc.(Formerly Ev3 Inc.)
Decision Date2016-09-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TrailBlazer Angled Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.(Formerly Ev3 Inc.). It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162384. 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 Angled Support Catheter?

TrailBlazer Angled Support Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Medtronic Vascular, Inc.(Formerly Ev3 Inc.). The 510(k) number is K162384.

When did TrailBlazer Angled Support Catheter receive FDA 510(k) clearance?

TrailBlazer Angled Support Catheter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162384.

Who is the listed applicant for TrailBlazer Angled Support Catheter?

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

What is the FDA product code for TrailBlazer Angled Support Catheter?

The FDA product code for TrailBlazer Angled Support Catheter is DQY.

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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