Cleared Traditional

K893626 - FLEXMEDICS GUIDEWIRE

K893626 is an FDA 510(k) clearance for FLEXMEDICS GUIDEWIRE, manufactured by Flexmedics. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K893626 · Flexmedics · Cardiovascular device
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Sep 1989
Decision
138d
Days
Class 2
Risk

K893626 is an FDA 510(k) clearance for the FLEXMEDICS GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Flexmedics (Findley, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 138 days - within the typical 510(k) review window.

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 Flexmedics devices

FDA 510(k) Submission Details - K893626

510(k) Number K893626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1989
Decision Date September 26, 1989
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
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 522
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K893626.
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