FDA 510(k)

Medtronic Stedi Extra Support Guidewire

K-Number: K250075 · 2025-06-13

Decision Date2025-06-13

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medtronic Stedi Extra Support Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250075. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Stedi Extra Support Guidewire?

Medtronic Stedi Extra Support Guidewire is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Medtronic, Inc.. The 510(k) number is K250075.

When did Medtronic Stedi Extra Support Guidewire receive FDA 510(k) clearance?

Medtronic Stedi Extra Support Guidewire received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250075.

Who is the listed applicant for Medtronic Stedi Extra Support Guidewire?

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

What is the FDA product code for Medtronic Stedi Extra Support Guidewire?

The FDA product code for Medtronic Stedi Extra Support Guidewire is DQX.

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Related Devices (Code: DQX)

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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.