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FDA 510(k)

AMPLATZER TORQVUE EXCHANGE SYSTEM

K-Number: K080994 · 2008-05-16

ApplicantAga Medical Corp.
Decision Date2008-05-16
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 Aga Medical Corp.. It received FDA 510(k) clearance on 2008-05-16 under 510(k) number K080994. 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 2008-05-16. The listed applicant is Aga Medical Corp.. The 510(k) number is K080994.

When did AMPLATZER TORQVUE EXCHANGE SYSTEM receive FDA 510(k) clearance?

AMPLATZER TORQVUE EXCHANGE SYSTEM received FDA 510(k) clearance on 2008-05-16, under 510(k) number K080994.

Who is the listed applicant for AMPLATZER TORQVUE EXCHANGE SYSTEM?

The FDA 510(k) record lists Aga Medical Corp. 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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Other records listing Aga Medical Corp. 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.

K113658AMPLATZER VASCULAR PLUG 4K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120K091793AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54K083214AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100K080757AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEMK072313AMPLATZER TORQVUE DELIVERY 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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.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 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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