Cleared Traditional

K013833 - HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL...

K013833 is the FDA 510(k) clearance for HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL... by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K013833 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
58d
Days
Class 2
Risk

K013833 is an FDA 510(k) clearance for the HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidant Corp. (Temecula, US). The FDA issued a Cleared decision on January 16, 2002 after a review of 58 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 Guidant Corp. devices

Submission Details

510(k) Number K013833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2001
Decision Date January 16, 2002
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 K013833.
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
K020340 · Guidant Corp. · Mar 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · Boston Scientific Corp · Feb 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · Advanced Cardiovascular Systems, Inc. · Jan 2002
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · Guidant Corp. · Dec 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp · Aug 2001
STREERABLE PTCA GUIDEWIRE
K011968 · Lake Region Mfg., Inc. · Jul 2001