Cleared Traditional

THE NAVIGATOR STEERABLE GUIDE WIRE (K860430) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860430 · Meadox Surgimed, Inc. · Cardiovascular device
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Jul 1986
Decision
164d
Days
Class 2
Risk

K860430 is an FDA 510(k) clearance for the THE NAVIGATOR STEERABLE GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on July 18, 1986 after a review of 164 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 Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K860430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date July 18, 1986
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
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 225
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K860430.
COATING FOR WIRE GUIDE
K880722 · Cook, Inc. · Aug 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · Shiley, Inc. · Jun 1986
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979