Cleared Traditional

K890959 - GUIDEWIRE

K890959 is an FDA 510(k) clearance for 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 197-day FDA review.

K890959 · Guidewire Technologies, Inc. · Cardiovascular device
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Sep 1989
Decision
197d
Days
Class 2
Risk

K890959 is an FDA 510(k) clearance for the 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 September 12, 1989 after a review of 197 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 Guidewire Technologies, Inc. devices

FDA 510(k) Submission Details - K890959

510(k) Number K890959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date September 12, 1989
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
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 K890959.
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · Cordis Corp. · Oct 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · Datascope Corp. · Oct 1989
FLEXMEDICS GUIDEWIRE
K893626 · Flexmedics · Sep 1989
USCI PROBE LINX EXTENSION WIRE
K890404 · C.R. Bard, Inc. · Aug 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · C.R. Bard, Inc. · Jun 1989
GUIDE WIRE INTRODUCER
K890807 · Datascope Corp. · Jun 1989