Cleared Traditional

K913178 - ACS VSW GUIDE WIRE

K913178 is the FDA 510(k) clearance for ACS VSW GUIDE WIRE by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K913178 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Oct 1991
Decision
83d
Days
Class 2
Risk

K913178 is an FDA 510(k) clearance for the ACS VSW GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K913178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1991
Decision Date October 08, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K913178.
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631 · Advanced Cardiovascular Systems, Inc. · Oct 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328 · Advanced Cardiovascular Systems, Inc. · Oct 1991
VASCULAR GUIDE WIRE
K913353 · Advanced Cardiovascular Systems, Inc. · Oct 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1991
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · Advanced Cardiovascular Systems, Inc. · Jun 1991