Cleared Traditional

K935232 - HYDROTORQUE GUIDE WIRE

K935232 is an FDA 510(k) clearance for HYDROTORQUE GUIDE WIRE, manufactured by Kingston Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K935232 · Kingston Technologies, Inc. · Cardiovascular device
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Jul 1994
Decision
261d
Days
Class 2
Risk

K935232 is an FDA 510(k) clearance for the HYDROTORQUE GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Kingston Technologies, Inc. (Dayton, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 261 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 Kingston Technologies, Inc. devices

FDA 510(k) Submission Details - K935232

510(k) Number K935232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date July 20, 1994
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
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 522
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K935232.
GUIDE WIRE
K942453 · Boston Scientific Corp · Dec 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · Scimed Life Systems, Inc. · Aug 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · Advanced Cardiovascular Systems, Inc. · Jul 1994
PLATINUM PLUS GUIDEWIRE
K935997 · Boston Scientific Corp · Jun 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994