Cleared Traditional

K926457 - SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR

K926457 is an FDA 510(k) clearance for SCIMED 0.038 CONTROLWIRE(TM) PERIPHER G..., manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K926457 · Scimed Life Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1993
Decision
105d
Days
Class 2
Risk

K926457 is an FDA 510(k) clearance for the SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 105 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 Life Systems, Inc. devices

FDA 510(k) Submission Details - K926457

510(k) Number K926457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date April 08, 1993
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K926457.
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961 · Target Therapeutics · May 1993
MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE
K925342 · Medtronics Interventional Vascular · May 1993
AMPLATZ GUIDEWIRES
K930622 · Meadox Medicals, Div. Boston Scientific Corp. · Apr 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
.25' ULTRA-SELECT GUIDEWIRE
K922060 · Microvena Corp. · Feb 1993