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FDA 510(k)

Medtronic Stedi Extra Support Guidewire

K-Number: K250075 · 2025-06-13

ApplicantMedtronic, Inc.
Decision Date2025-06-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medtronic Stedi Extra Support Guidewire is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2025-06-13 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K250075.

When was Medtronic Stedi Extra Support Guidewire approved by the FDA?

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

What company makes Medtronic Stedi Extra Support Guidewire?

Medtronic Stedi Extra Support Guidewire is manufactured by Medtronic, Inc..

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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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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