Cleared Traditional

SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. (K931584) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931584 · Scimed · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
92d
Days
Class 2
Risk

K931584 is an FDA 510(k) clearance for the SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed (Plymouth, US). The FDA issued a Cleared decision on July 1, 1993 after a review of 92 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K931584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date July 01, 1993
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 226
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K931584.
MAGIC TORQUE GUIDEWIRE
K933334 · Boston Scientific Corp · Jan 1994
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · Cordis Corp. · Apr 1993
USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
K925074 · C.R. Bard, Inc. · Mar 1993
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993