Cleared Traditional

K003084 - CONCENTRIC HYDROPHILIC GUIDEWIRE

K003084 is the FDA 510(k) clearance for CONCENTRIC HYDROPHILIC GUIDEWIRE by Concentric Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K003084 · Concentric Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
225d
Days
Class 2
Risk

K003084 is an FDA 510(k) clearance for the CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Moutian View, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 225 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.

View all Concentric Medical, Inc. devices

Submission Details

510(k) Number K003084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date May 16, 2001
Days to Decision 225 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
100d slower than avg
Panel avg: 125d · This submission: 225d
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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K003084.
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
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