Cleared Traditional

K943390 - FLEXFINDER GUIDEWIRE

K943390 is an FDA 510(k) clearance for FLEXFINDER 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 348-day FDA review.

K943390 · Flexmedics · Cardiovascular device
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Jun 1995
Decision
348d
Days
Class 2
Risk

K943390 is an FDA 510(k) clearance for the FLEXFINDER GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Flexmedics (Minnetonka, US). The FDA issued a Cleared decision on June 27, 1995 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K943390

510(k) Number K943390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date June 27, 1995
Days to Decision 348 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 125d · This submission: 348d
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 K943390.
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · Cordis Corp. · Jul 1995
URESIL(R) GUIDEWIRE
K945934 · Uresil Corp. · Jul 1995
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE
K950216 · Scimed Life Systems, Inc. · Jun 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · Baxter Healthcare Corp · Jun 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · Boston Scientific Corp · Jun 1995