Cleared Traditional

K945934 - URESIL GUIDEWIRE

K945934 is an FDA 510(k) clearance for URESIL GUIDEWIRE, manufactured by Uresil Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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

FDA 510(k) Submission Details - K945934

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
Combination Product No
PCCP Authorized No
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.

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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K945934.
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
K952562 · Cardio Metrics, Inc. · Aug 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · Cordis 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