Cleared Traditional

K922674 - NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE

K922674 is an FDA 510(k) clearance for NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE, manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K922674 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
200d
Days
Class 2
Risk

K922674 is an FDA 510(k) clearance for the NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 200 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 Medicals, Div. Boston Scientific Corp. devices

FDA 510(k) Submission Details - K922674

510(k) Number K922674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date December 21, 1992
Days to Decision 200 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
75d slower than avg
Panel avg: 125d · This submission: 200d
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 703
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K922674.
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · Peripheral Systems Group · Feb 1993
CORDIS VIERA GUIDEWIRE
K923696 · Cordis Corp. · Feb 1993
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · Cook, Inc. · Dec 1992
TAPER GUIDEWIRES
K924987 · Target Therapeutics · Dec 1992
RADIFOCUS(R) (CATHETER) GUIDE WIRE
K924202 · Terumo Medical Corp. · Nov 1992
SEEKER LITE - 10
K922912 · Target Therapeutics · Nov 1992