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FDA 510(k)

Tigereye CTO-Crossing Catheter

K-Number: K212468 · 2022-01-06

ApplicantAvinger, Inc.
Decision Date2022-01-06
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tigereye 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 2022-01-06 under 510(k) number K212468. 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 CTO-Crossing Catheter?

Tigereye CTO-Crossing Catheter is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Avinger, Inc.. The 510(k) number is K212468.

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

Tigereye CTO-Crossing Catheter received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212468.

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

The FDA product code for Tigereye 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.

K230005Pantheris LV Atherectomy CatheterK230594Tigereye ST CTO-Crossing CatheterK212047Pantheris SystemK201330Tigereye CTO-Crossing CatheterK182341Pantheris SVK173862Pantheris System

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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.K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.

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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