Cleared Traditional

K931584 - SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.

K931584 is an FDA 510(k) clearance for SCIMED TRANSPORT STEERABLE GUIDE WIRE A..., manufactured by Scimed. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K931584 · Scimed · Cardiovascular device
Download Printable Device Report (PDF)
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.

View all Scimed devices

FDA 510(k) Submission Details - K931584

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.

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 677
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K931584.
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385 · Arrow Intl., Inc. · Aug 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327 · Peripheral Systems Group · Jul 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
K930787 · Advanced Surgical, Inc. · Jul 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514 · Scimed Life Systems, Inc. · Jun 1993
SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI
K931577 · Schneider Intl., Ltd. · Jun 1993
TERUMO CORONARY GUIDE WIRE
K925852 · Terumo Medical Corp. · Jun 1993