Cleared Traditional

K952860 - THE NINER NITINOL GUIDEWIRE

K952860 is an FDA 510(k) clearance for THE NINER NITINOL GUIDEWIRE, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K952860 · Microvena Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
174d
Days
Class 2
Risk

K952860 is an FDA 510(k) clearance for the THE NINER NITINOL GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Microvena Corp. (White Bear Lake, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 174 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 Microvena Corp. devices

FDA 510(k) Submission Details - K952860

510(k) Number K952860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1995
Decision Date December 13, 1995
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 617
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K952860.
CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
K955551 · Cardio Metrics, Inc. · Feb 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · Terumo Medical Corp. · Feb 1996
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896 · Datascope Corp. · Dec 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · Cordis Corp. · Nov 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
K954913 · Cardio Metrics, Inc. · Nov 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · Terumo Medical Corp. · Oct 1995