Cleared Traditional

K003084 - CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012

K003084 is an FDA 510(k) clearance for CONCENTRIC HYDROPHILIC GUIDEWIRE, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K003084

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.

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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K003084.
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STREERABLE PTCA GUIDEWIRE
K011968 · Lake Region Mfg., Inc. · Jul 2001
MANDREL GUIDEWIRE ASSEMBLY
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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