Cleared Traditional

K873403 - CORDIS STEERABLE GUIDEWIRE

K873403 is an FDA 510(k) clearance for CORDIS STEERABLE GUIDEWIRE, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K873403 · Cordis Corp. · Cardiovascular device
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Mar 1988
Decision
211d
Days
Class 2
Risk

K873403 is an FDA 510(k) clearance for the CORDIS STEERABLE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 211 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 Cordis Corp. devices

FDA 510(k) Submission Details - K873403

510(k) Number K873403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date March 22, 1988
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K873403.
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · Advanced Cardiovascular Systems, Inc. · Jul 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · Advanced Cardiovascular Systems, Inc. · Apr 1988
GUIDE WIRE INTRODUCER
K873972 · Target Therapeutics · Apr 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · Advanced Cardiovascular Systems, Inc. · Feb 1988
TELEFLEX STEERABLE GUIDEWIRE
K871850 · Teleflexmedical, Inc. · Jan 1988
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987