Cleared Traditional

K860432 - PERCUTANEOUS INTRODUCER KIT

K860432 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER KIT, manufactured by Cormed, Inc., Sub. C.R.Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K860432 · Cormed, Inc., Sub. C.R.Bard, Inc. · Cardiovascular device
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Mar 1986
Decision
55d
Days
Class 2
Risk

K860432 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cormed, Inc., Sub. C.R.Bard, Inc. (Medina, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Cormed, Inc., Sub. C.R.Bard, Inc. devices

FDA 510(k) Submission Details - K860432

510(k) Number K860432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date March 31, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 645
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K860432.
PMS PERCUTANEOUS PUNCTURE NEEDLE
K854941 · Professional Medical Services · Apr 1986
CURITY PERCUTANEOUS CATHETER INSERTION TRAY
K855060 · The Kendal Co. · Apr 1986
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · The Kendal Co. · Apr 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90
K853072 · Camino Laboratories, Inc. · Dec 1985