Cleared Traditional

K022762 - JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

K022762 is an FDA 510(k) clearance for JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, manufactured by Jomed, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K022762 · Jomed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
118d
Days
Class 2
Risk

K022762 is an FDA 510(k) clearance for the JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, A.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Jomed, Inc. (San Diego, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 118 days - within the typical 510(k) review window.

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 Jomed, Inc. devices

FDA 510(k) Submission Details - K022762

510(k) Number K022762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2002
Decision Date December 16, 2002
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
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 668
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K022762.
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc. · May 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc. · Feb 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp. · Jan 2003
ENDOVASCULAR GUIDE WIRE
K021363 · Stereotaxis, Inc. · Nov 2002
HI-TORQUE WHISPER LS
K023300 · Guidant Corp. · Oct 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target · Oct 2002