Cleared Traditional

K914194 - SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE

K914194 is an FDA 510(k) clearance for SCIMED CONTROLWIRE(TM) GUIDE WIRE, 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 265-day FDA review.

K914194 · Scimed Life Systems, Inc. · Cardiovascular device
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Jun 1992
Decision
265d
Days
Class 2
Risk

K914194 is an FDA 510(k) clearance for the SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 265 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K914194

510(k) Number K914194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date June 09, 1992
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
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 684
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K914194.
MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
K921702 · Merit Medical Systems, Inc. · Sep 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302 · Boston Scientific Corp · Jul 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410 · Scimed Life Systems, Inc. · Jul 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · Advanced Cardiovascular Systems, Inc. · Jun 1992
GUIDE WIRES, MODIFICATION
K914986 · E-Z-Em, Inc. · May 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
K914531 · Arrow Intl., Inc. · Feb 1992