Cleared Traditional

K854912 - ANGIOMED GUIED WIRES

K854912 is the FDA 510(k) clearance for ANGIOMED GUIED WIRES by Angiomed U.S., Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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 502
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