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FDA 510(k)

RELIANT STENT GRAFT BALLOON CATHETER

K-Number: K050038 · 2005-04-13

ApplicantMedtronic Endovascular Innovations
Decision Date2005-04-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RELIANT STENT GRAFT BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Endovascular Innovations. It received FDA 510(k) clearance on 2005-04-13 under 510(k) number K050038. 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 RELIANT STENT GRAFT BALLOON CATHETER?

RELIANT STENT GRAFT BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2005-04-13. The listed applicant is Medtronic Endovascular Innovations. The 510(k) number is K050038.

When did RELIANT STENT GRAFT BALLOON CATHETER receive FDA 510(k) clearance?

RELIANT STENT GRAFT BALLOON CATHETER received FDA 510(k) clearance on 2005-04-13, under 510(k) number K050038.

Who is the listed applicant for RELIANT STENT GRAFT BALLOON CATHETER?

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

What is the FDA product code for RELIANT STENT GRAFT BALLOON CATHETER?

The FDA product code for RELIANT STENT GRAFT BALLOON CATHETER is DQY.

Related Clinical Trials

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.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 CatheterAbbott

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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