Cleared Traditional

GUIDEWIRE (K890959) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K890959.
DATASCOPE STEERING HANDLE
K894940 · Datascope Corp. · Nov 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · Cordis Corp. · Oct 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · Datascope Corp. · Oct 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