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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 the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2023-04-25 under 510(k) 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. The listed applicant is Avinger, Inc.. The 510(k) number is K230594.

When did Tigereye ST CTO-Crossing Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Tigereye ST CTO-Crossing Catheter?

The FDA 510(k) record lists Avinger, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

NCT06795763Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional ProceduresENROLLING_BY_INVITATION

Other records listing Avinger, Inc. as applicant

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.

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Related Devices (Code: PDU)

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.

K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.K221163Tunnel Crossing CatheterTractus Vascular, LLC

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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