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FDA 510(k)

Amplatzer Trevisio Intravascular Delivery System

K-Number: K190581 · 2019-04-05

ApplicantABBOTT MEDICAL
Decision Date2019-04-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amplatzer Trevisio Intravascular Delivery System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-04-05 under approval number K190581. 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 Trevisio Intravascular Delivery System?

Amplatzer Trevisio Intravascular Delivery System is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K190581.

When was Amplatzer Trevisio Intravascular Delivery System approved by the FDA?

Amplatzer Trevisio Intravascular Delivery System received FDA 510(k) clearance on 2019-04-05, under approval number K190581.

What company makes Amplatzer Trevisio Intravascular Delivery System?

Amplatzer Trevisio Intravascular Delivery System is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Amplatzer Trevisio Intravascular Delivery System?

The FDA product code for Amplatzer Trevisio Intravascular Delivery System 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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