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FDA 510(k)

Amplatzer TorqVue Delivery System

K-Number: K260993 · 2026-04-24

ApplicantAbbott
Decision Date2026-04-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amplatzer TorqVue Delivery System is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2026-04-24 under approval number K260993. 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 Amplatzer TorqVue Delivery System?

Amplatzer TorqVue Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Abbott. The 510(k) number is K260993.

When was Amplatzer TorqVue Delivery System approved by the FDA?

Amplatzer TorqVue Delivery System received FDA 510(k) clearance on 2026-04-24, under approval number K260993.

What company makes Amplatzer TorqVue Delivery System?

Amplatzer TorqVue Delivery System is manufactured by Abbott.

What is the FDA product code for Amplatzer TorqVue Delivery System?

The FDA product code for Amplatzer TorqVue Delivery System is DQY.

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Related Devices (Code: DQY)

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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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