Cleared Traditional

URESIL(R) GUIDEWIRE (K945934) - FDA 510(k) Clearance

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

K945934 · Uresil Corp. · Cardiovascular device
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Jul 1995
Decision
217d
Days
Class 2
Risk

K945934 is an FDA 510(k) clearance for the URESIL(R) GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on July 10, 1995 after a review of 217 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 Uresil Corp. devices

Submission Details

510(k) Number K945934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1994
Decision Date July 10, 1995
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K945934.
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · Terumo Medical Corp. · Oct 1995
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · Cordis Corp. · Jul 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
PRECEDER GUIDEWIRE
K950352 · Boston Scientific Corp · Apr 1995