Cleared Traditional

K854830 - ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES

K854830 is the FDA 510(k) clearance for ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K854830 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 1986
Decision
118d
Days
Class 2
Risk

K854830 is an FDA 510(k) clearance for the ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 118 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K854830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date March 31, 1986
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K854830.
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
(.O38) HI-TORQUE GUIDE WIRES
K860533 · Target Therapeutics · Mar 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · Dlp, Inc. · Feb 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511 · Electro-Catheter Corp. · Feb 1986