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FDA 510(k)

Amplatzer TorqVue Exchange System

K-Number: K261631 · 2026-06-17

ApplicantAbbott Medical
Decision Date2026-06-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amplatzer TorqVue Exchange System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261631. 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 Exchange System?

Amplatzer TorqVue Exchange System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Abbott Medical. The 510(k) number is K261631.

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

Amplatzer TorqVue Exchange System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261631.

Who is the listed applicant for Amplatzer TorqVue Exchange System?

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

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

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

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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.

K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.K260993Amplatzer TorqVue Delivery SystemAbbottK253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.

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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