Cleared Traditional

K180416 - ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

K180416 is an FDA 510(k) clearance for ViperWire Advance Guide Wire, manufactured by Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K180416 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
61d
Days
Class 2
Risk

K180416 is an FDA 510(k) clearance for the ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Devi.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on April 17, 2018 after a review of 61 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. 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 Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K180416

510(k) Number K180416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date April 17, 2018
Days to Decision 61 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
64d faster than avg
Panel avg: 125d · This submission: 61d
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 100
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K180416.
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · Cardiovascular Systems, Inc. · Dec 2018
B-Laser Atherectomy System
K181642 · Eximo Medical, Ltd. · Oct 2018
Pantheris System
K173862 · Avinger, Inc. · May 2018
Straub Endovascular System
K172315 · Straub Medical AG · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K172687 · Spectranetics, Inc. · Nov 2017