Cleared Traditional

K230005 - Pantheris LV Atherectomy Catheter

K230005 is an FDA 510(k) clearance for Pantheris LV Atherectomy Catheter, manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K230005 · Avinger, Inc. · Cardiovascular device
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Jun 2023
Decision
154d
Days
Class 2
Risk

K230005 is an FDA 510(k) clearance for the Pantheris LV Atherectomy Catheter. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 6, 2023 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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

FDA 510(k) Submission Details - K230005

510(k) Number K230005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2023
Decision Date June 06, 2023
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K230005.
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
K233668 · Eximo Medical, Ltd. · Dec 2023
FreedomFlow Orbital Circumferential Atherectomy System
K231538 · Cardio Flow Inc., · Sep 2023
Auryon Atherectomy System
K230709 · Eximo Medical, Ltd. · Jun 2023
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K222837 · Spectranetics, Inc. · Dec 2022
Auryon Atherectomy Catheters
K220116 · Eximo Medical, Ltd. · Sep 2022
ROTAPRO Rotational Atherectomy System
K220962 · Boston Scientific Corporation · Sep 2022