Cleared Traditional

K902152 - MOVABLE CORE GUIDEWIRE

K902152 is an FDA 510(k) clearance for MOVABLE CORE GUIDEWIRE, manufactured by Guidewire Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K902152 · Guidewire Technologies, Inc. · Cardiovascular device
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Jul 1990
Decision
77d
Days
Class 2
Risk

K902152 is an FDA 510(k) clearance for the MOVABLE CORE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidewire Technologies, Inc. (Salem, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 77 days - a notably fast clearance 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: 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 Guidewire Technologies, Inc. devices

FDA 510(k) Submission Details - K902152

510(k) Number K902152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date July 31, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
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 712
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K902152.
ROADRUNNER WIRE GUIDE
K901899 · Cook, Inc. · Sep 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · Advanced Cardiovascular Systems, Inc. · Sep 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · Advanced Cardiovascular Systems, Inc. · Aug 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · Datascope Corp. · Jun 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · Advanced Cardiovascular Systems, Inc. · Jun 1990
INSITE STEERABLE GUIDEWIRE
K901224 · Lake Region Mfg., Inc. · Jun 1990