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FDA 510(k)

TorqVue Low Profile Delivery Catheter

K-Number: K162228 · 2016-09-09

ApplicantAga Medical Corporation (Wholly Owned by St.Jude Medical Cor
Decision Date2016-09-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TorqVue Low Profile Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K162228. 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 TorqVue Low Profile Delivery Catheter?

TorqVue Low Profile Delivery Catheter is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. The 510(k) number is K162228.

When did TorqVue Low Profile Delivery Catheter receive FDA 510(k) clearance?

TorqVue Low Profile Delivery Catheter received FDA 510(k) clearance on 2016-09-09, under 510(k) number K162228.

Who is the listed applicant for TorqVue Low Profile Delivery Catheter?

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

What is the FDA product code for TorqVue Low Profile Delivery Catheter?

The FDA product code for TorqVue Low Profile Delivery Catheter is DQY.

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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