Cleared Traditional

K895899 - FLEXMEDICS GUIDEWIRE .012 ONLY

K895899 is an FDA 510(k) clearance for FLEXMEDICS GUIDEWIRE .012 ONLY, manufactured by Flexmedics. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K895899 · Flexmedics · Cardiovascular device
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May 1990
Decision
229d
Days
Class 2
Risk

K895899 is an FDA 510(k) clearance for the FLEXMEDICS GUIDEWIRE .012 ONLY. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Flexmedics (Findley, US). The FDA issued a Cleared decision on May 23, 1990 after a review of 229 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 Flexmedics devices

FDA 510(k) Submission Details - K895899

510(k) Number K895899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1989
Decision Date May 23, 1990
Days to Decision 229 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 125d · This submission: 229d
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 K895899.
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
CRAGG CONVERTIBLE WIRE
K897152 · Boston Scientific Corp · Feb 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · Advanced Cardiovascular Systems, Inc. · Feb 1990
DATASCOPE STEERING HANDLE
K894940 · Datascope Corp. · Nov 1989