Cleared Traditional

K212468 - Tigereye CTO-Crossing Catheter

K212468 is the FDA 510(k) clearance for Tigereye CTO-Crossing Catheter by Avinger, Inc.. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K212468 · Avinger, Inc. · Cardiovascular device
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Jan 2022
Decision
153d
Days
Class 2
Risk

K212468 is an FDA 510(k) clearance for the Tigereye 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 January 6, 2022 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Avinger, Inc. devices

Submission Details

510(k) Number K212468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2021
Decision Date January 06, 2022
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K212468.
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
GoBack Crossing Catheter
K211802 · Upstream Peripheral Technologies, Ltd. · Mar 2022
Crosser iQ CTO Recanalization System
K203363 · C.R. Bard, Inc. · Aug 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · Ra Medical Systems,Inc · Jul 2021
SoundBite Crossing System - Peripheral (14P)
K210839 · Soundbite Medical Solutions, Inc. · Apr 2021