Cleared Traditional

K112674 - NAVIS TORQUER

K112674 is an FDA 510(k) clearance for NAVIS TORQUER, manufactured by Navis Medical,Inc. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K112674 · Navis Medical,Inc · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
296d
Days
Class 2
Risk

K112674 is an FDA 510(k) clearance for the NAVIS TORQUER. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Navis Medical,Inc (Galena, US). The FDA issued a Cleared decision on July 6, 2012 after a review of 296 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.

FDA 510(k) Submission Details - K112674

510(k) Number K112674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2011
Decision Date July 06, 2012
Days to Decision 296 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
171d slower than avg
Panel avg: 125d · This submission: 296d
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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K112674.
SLIDEWIRETM(TRADEMARK PENDING)
K113162 · Acme-Monaco Corp. · Jul 2012
DISPOSABLE TORQUE DEVICE
K113498 · Coeur, Inc. · Jul 2012
MANTARAY GUIDEWIRES
K121745 · Bridgepoint Medical · Jul 2012
SUNMED GUIDE WIRE
K120119 · Sunny Medical Device (Shenzhen) Co., Ltd. · May 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
K120298 · St. Jude Medical, Cardiac Rhythm Management Divisi · May 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
K112674 · NAVIS TORQUER
Download PDF FDA Summary Navis Medical,Inc