Cleared Traditional

K922536 - TORQUE DEVICE

K922536 is the FDA 510(k) clearance for TORQUE DEVICE by Procedure Products, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K922536 · Procedure Products, Inc. · Cardiovascular device
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Dec 1992
Decision
196d
Days
Class 2
Risk

K922536 is an FDA 510(k) clearance for the TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 196 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 Procedure Products, Inc. devices

Submission Details

510(k) Number K922536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date December 10, 1992
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 451
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K922536.
CORDIS VIERA GUIDEWIRE
K923696 · Cordis Corp. · Feb 1993
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · Cook, Inc. · Dec 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1992
TAPER GUIDEWIRES
K924987 · Target Therapeutics · Dec 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202 · Terumo Medical Corp. · Nov 1992
SEEKER LITE - 10
K922912 · Target Therapeutics · Nov 1992