Cleared Traditional

K951109 - C-THRU CORONARY GUIDE WIRE

K951109 is an FDA 510(k) clearance for C-THRU CORONARY GUIDE WIRE, manufactured by Schneider (Europe) GmbH. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K951109 · Schneider (Europe) GmbH · Cardiovascular device
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Jun 1995
Decision
90d
Days
Class 2
Risk

K951109 is an FDA 510(k) clearance for the C-THRU CORONARY GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Schneider (Europe) GmbH (Bulach, SE). The FDA issued a Cleared decision on June 8, 1995 after a review of 90 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 Schneider (Europe) GmbH devices

FDA 510(k) Submission Details - K951109

510(k) Number K951109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date June 08, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K951109.
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
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358 · Meadox Medicals, Div. Boston Scientific Corp. · Jun 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835 · Scimed Life Systems, Inc. · May 1995