Cleared Traditional

K914194 - SCIMED CONTROLWIRE(TM) GUIDE WIRE

K914194 is the FDA 510(k) clearance for SCIMED CONTROLWIRE(TM) GUIDE WIRE by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K914194 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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