Cleared Traditional

K874202 - ACS HI-TORQUE GUIDE WIRES

K874202 is the FDA 510(k) clearance for ACS HI-TORQUE GUIDE WIRES by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K874202 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Apr 1988
Decision
196d
Days
Class 2
Risk

K874202 is an FDA 510(k) clearance for the ACS HI-TORQUE GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 196 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K874202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date April 28, 1988
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K874202.
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · Advanced Cardiovascular Systems, Inc. · Aug 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332 · Medrad, Inc. · Jul 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · Advanced Cardiovascular Systems, Inc. · Jul 1988
GUIDE WIRE INTRODUCER
K873972 · Target Therapeutics · Apr 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · Advanced Cardiovascular Systems, Inc. · Feb 1988