Cleared Traditional

K860580 - ACS BRACHIAL CORONARY GUIDING CATH W/TA...

K860580 is the FDA 510(k) clearance for ACS BRACHIAL CORONARY GUIDING CATH W/TA... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K860580 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Mar 1986
Decision
41d
Days
Class 2
Risk

K860580 is an FDA 510(k) clearance for the ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP. Classified as Catheter, Intravascular, Diagnostic (product code DQO), 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 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K860580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1986
Decision Date March 31, 1986
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K860580.
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867 · Medical Components, Inc. · Jul 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · Cordis Corp. · Jun 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483 · Mallinckrodt Critical Care · May 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · Mallinckrodt Critical Care · Jan 1986
LAP-CATH
K852197 · Research Medical, Inc. · Nov 1985