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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 a medical device manufactured by Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. It received FDA 510(k) clearance on 2016-09-09 under approval 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. It is manufactured by Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. The 510(k) number is K162228.

When was TorqVue Low Profile Delivery Catheter approved by the FDA?

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

What company makes TorqVue Low Profile Delivery Catheter?

TorqVue Low Profile Delivery Catheter is manufactured by Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor.

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

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

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Related Devices (Code: DQY)

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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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