Cleared Special

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K222837) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222837 · Spectranetics, Inc. · Cardiovascular device
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Dec 2022
Decision
79d
Days
Class 2
Risk

K222837 is an FDA 510(k) clearance for the Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser At.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on December 8, 2022 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spectranetics, Inc. devices

Submission Details

510(k) Number K222837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2022
Decision Date December 08, 2022
Days to Decision 79 days
Submission Type Special
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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 39
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K222837.
FreedomFlow Orbital Circumferential Atherectomy System
K231538 · Cardio Flow Inc., · Sep 2023
Auryon Atherectomy System
K230709 · Eximo Medical, Ltd. · Jun 2023
Pantheris LV Atherectomy Catheter
K230005 · Avinger, Inc. · Jun 2023
Auryon Atherectomy Catheters
K220116 · Eximo Medical, Ltd. · Sep 2022
ROTAPRO Rotational Atherectomy System
K220962 · Boston Scientific Corporation · Sep 2022
Auryon Atherectomy System
K221077 · Eximo Medical, Ltd. · Jun 2022