Cleared Traditional

K854912 - ANGIOMED GUIED WIRES

K854912 is an FDA 510(k) clearance for ANGIOMED GUIED WIRES, manufactured by Angiomed U.S., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K854912 · Angiomed U.S., Inc. · Cardiovascular device
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Apr 1986
Decision
128d
Days
Class 2
Risk

K854912 is an FDA 510(k) clearance for the ANGIOMED GUIED WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on April 16, 1986 after a review of 128 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 Angiomed U.S., Inc. devices

FDA 510(k) Submission Details - K854912

510(k) Number K854912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date April 16, 1986
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
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 689
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K854912.
TELEFLEX TEFLON COATED GUIDEWIRE
K860258 · Teleflexmedical, Inc. · May 1986
GUIDE WIRE INTRODUCER
K860841 · Target Therapeutics · Apr 1986
GUIDED WIRE TORQUER
K860840 · Target Therapeutics · Apr 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · Advanced Cardiovascular Systems, Inc. · Mar 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533 · Target Therapeutics · Mar 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · Dlp, Inc. · Feb 1986