Cleared Traditional

K926457 - SCIMED 0.038 CONTROLWIRE(TM) PERIPHER G...

K926457 is the FDA 510(k) clearance for SCIMED 0.038 CONTROLWIRE(TM) PERIPHER G... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 K926457.
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · Advanced Cardiovascular Systems, Inc. · Jun 1993
CATHETER GUIDEWIRE (PERIPHERAL USE)
K930961 · Target Therapeutics · 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
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · Advanced Cardiovascular Systems, Inc. · Feb 1993