Cleared Traditional

K230594 - Tigereye ST CTO-Crossing Catheter

K230594 is an FDA 510(k) clearance for Tigereye ST CTO-Crossing Catheter, manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K230594 · Avinger, Inc. · Cardiovascular device
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Apr 2023
Decision
53d
Days
Class 2
Risk

K230594 is an FDA 510(k) clearance for the Tigereye ST CTO-Crossing Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 25, 2023 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avinger, Inc. devices

FDA 510(k) Submission Details - K230594

510(k) Number K230594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date April 25, 2023
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 39
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K230594.
LimFlow ARC
K251376 · LimFlow, Inc. · May 2025
PowerWire Radiofrequency Guidewire Kit
K232562 · Baylis Medical Technologies, Inc. · Feb 2024
SoundBite® Crossing System XS Peripheral
K230159 · Soundbite Medical Solutions, Inc. · Aug 2023
Tunnel Crossing Catheter
K221163 · Tractus Vascular, LLC · Jan 2023
LimFlow ARC
K221541 · LimFlow, Inc. · Aug 2022
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
K220544 · Ra Medical Systems,Inc · Jun 2022