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FDA 510(k)

AMPLATZER TORQ VUE LP DELIVERY SYSTEM

K-Number: K131063 · 2013-08-15

ApplicantSt Jude Medical
Decision Date2013-08-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER TORQ VUE LP DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K131063. 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 TORQ VUE LP DELIVERY SYSTEM?

AMPLATZER TORQ VUE LP DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is St Jude Medical. The 510(k) number is K131063.

When did AMPLATZER TORQ VUE LP DELIVERY SYSTEM receive FDA 510(k) clearance?

AMPLATZER TORQ VUE LP DELIVERY SYSTEM received FDA 510(k) clearance on 2013-08-15, under 510(k) number K131063.

Who is the listed applicant for AMPLATZER TORQ VUE LP DELIVERY SYSTEM?

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

What is the FDA product code for AMPLATZER TORQ VUE LP DELIVERY SYSTEM?

The FDA product code for AMPLATZER TORQ VUE LP DELIVERY 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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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