Cleared Traditional

K113162 - SLIDEWIRETM(TRADEMARK PENDING)

K113162 is an FDA 510(k) clearance for SLIDEWIRETM(TRADEMARK PENDING), manufactured by Acme-Monaco Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K113162 · Acme-Monaco Corp. · Cardiovascular device
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Jul 2012
Decision
268d
Days
Class 2
Risk

K113162 is an FDA 510(k) clearance for the SLIDEWIRETM(TRADEMARK PENDING). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Acme-Monaco Corp. (New Britain, US). The FDA issued a Cleared decision on July 20, 2012 after a review of 268 days - an extended review 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: 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 Acme-Monaco Corp. devices

FDA 510(k) Submission Details - K113162

510(k) Number K113162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2011
Decision Date July 20, 2012
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 685
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K113162.
MERIT HYDROPHILIC GUIDE WIRE
K120644 · Merit Medical Systems, Inc. · Sep 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
K122506 · Surefire Medical, Inc. · Sep 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · Codman & Shurtleff, Inc. · Aug 2012
DISPOSABLE TORQUE DEVICE
K113498 · Coeur, Inc. · Jul 2012
MANTARAY GUIDEWIRES
K121745 · Bridgepoint Medical · Jul 2012
NAVIS TORQUER
K112674 · Navis Medical,Inc · Jul 2012