Cleared Traditional

K936032 - TORQUE DEVICE

K936032 is the FDA 510(k) clearance for TORQUE DEVICE by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K936032 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
88d
Days
Class 2
Risk

K936032 is an FDA 510(k) clearance for the TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K936032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date March 15, 1994
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K936032.
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994
ONTRAC STEERABLE GUIDEWIRE
K941229 · Lake Region Mfg., Inc. · May 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
K935170 · Lake Region Mfg., Inc. · Mar 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · Scimed Life Systems, Inc. · Mar 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982 · Cordis Corp. · Feb 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · Scimed Life Systems, Inc. · Feb 1994