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FDA 510(k)

Amplatzer Guidewire

K-Number: K250031 · 2025-10-03

ApplicantABBOTT MEDICAL
Decision Date2025-10-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amplatzer Guidewire is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-10-03 under approval number K250031. 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 Amplatzer Guidewire?

Amplatzer Guidewire is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K250031.

When was Amplatzer Guidewire approved by the FDA?

Amplatzer Guidewire received FDA 510(k) clearance on 2025-10-03, under approval number K250031.

What company makes Amplatzer Guidewire?

Amplatzer Guidewire is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Amplatzer Guidewire?

The FDA product code for Amplatzer 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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