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FDA 510(k)

Tigereye ST CTO-Crossing Catheter

K-Number: K230594 · 2023-04-25

ApplicantAvinger, Inc.
Decision Date2023-04-25
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tigereye ST CTO-Crossing Catheter is a medical device manufactured by Avinger, Inc.. It received FDA 510(k) clearance on 2023-04-25 under approval number K230594. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigereye ST CTO-Crossing Catheter?

Tigereye ST CTO-Crossing Catheter is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Avinger, Inc.. The 510(k) number is K230594.

When was Tigereye ST CTO-Crossing Catheter approved by the FDA?

Tigereye ST CTO-Crossing Catheter received FDA 510(k) clearance on 2023-04-25, under approval number K230594.

What company makes Tigereye ST CTO-Crossing Catheter?

Tigereye ST CTO-Crossing Catheter is manufactured by Avinger, Inc..

What is the FDA product code for Tigereye ST CTO-Crossing Catheter?

The FDA product code for Tigereye ST CTO-Crossing Catheter is PDU.

Other Devices by Avinger, Inc.

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Related Devices (Code: PDU)

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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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