Cleared Abbreviated

K003394 - APPALEAD GW+03XXXXXXR SERIES

K003394 is the FDA 510(k) clearance for APPALEAD GW+03XXXXXXR SERIES by Nipro Medical Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K003394 · Nipro Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
90d
Days
Class 2
Risk

K003394 is an FDA 510(k) clearance for the APPALEAD GW+03XXXXXXR SERIES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Miami, US). The FDA issued a Cleared decision on January 30, 2001 after a review of 90 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nipro Medical Corp. devices

Submission Details

510(k) Number K003394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2000
Decision Date January 30, 2001
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 519
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K003394.
MANDREL GUIDEWIRE ASSEMBLY
K011084 · Lake Region Mfg., Inc. · May 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · Micro Therapeutics, Inc. · Mar 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · Cordis Neurovascular, Inc. · Mar 2001
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · Lake Region Mfg., Inc. · Dec 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc. · Oct 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp. · Aug 2000