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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2026-04-24 under 510(k) 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. The listed applicant is Abbott. The 510(k) number is K260993.

When did Amplatzer TorqVue Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for Amplatzer TorqVue Delivery System?

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

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

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

Other records listing Abbott as applicant

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.

K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterPMA P170038Ventricular (assist) bypassK251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)K233655Lingo Glucose SystemK222297CentriMag Pre-connected PackK221213EnSite X EP System

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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.

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 CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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