Cleared Traditional

K180416 - ViperWire Advance Guide Wire

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

K180416 · Cardiovascular Systems, Inc. · Cardiovascular device
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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

Submission Details

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.

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 47
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
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HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014