Cleared Traditional

K013810 - CARDIOVASCULAR ARRAY

K013810 is the FDA 510(k) clearance for CARDIOVASCULAR ARRAY by W.L. Gore & Associates, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K013810 · W.L. Gore & Associates, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
12d
Days
Class 2
Risk

K013810 is an FDA 510(k) clearance for the CARDIOVASCULAR ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Newark, US). The FDA issued a Cleared decision on November 27, 2001 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K013810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date November 27, 2001
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 Radiology devices follow this clearance model.

Regulatory Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 309
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K013810.
SHOULDER COIL
K013541 · Usa Instruments, Inc. · Dec 2001
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NURVO 9000 ENDOCAVITARY COILS
K011683 · Usa Instruments, Inc. · Dec 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · Mri Devices Corp. · Nov 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · Mri Devices Corp. · Nov 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · Mri Devices Corp. · Oct 2001