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FDA 510(k)

AMPLATZER TorqVue 45x45 Delivery Sheath

K-Number: K163000 · 2016-12-23

ApplicantAga Medical COrporation (Wholly Owned by St. Jude Medical CO
Decision Date2016-12-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER TorqVue 45x45 Delivery Sheath is a medical device manufactured by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. It received FDA 510(k) clearance on 2016-12-23 under approval number K163000. 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 45x45 Delivery Sheath?

AMPLATZER TorqVue 45x45 Delivery Sheath is a medical device that received FDA 510(k) clearance on 2016-12-23. It is manufactured by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The 510(k) number is K163000.

When was AMPLATZER TorqVue 45x45 Delivery Sheath approved by the FDA?

AMPLATZER TorqVue 45x45 Delivery Sheath received FDA 510(k) clearance on 2016-12-23, under approval number K163000.

What company makes AMPLATZER TorqVue 45x45 Delivery Sheath?

AMPLATZER TorqVue 45x45 Delivery Sheath is manufactured by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO.

What is the FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath is 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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