Cleared Traditional

K904475 - ENTREE SHEATH INTRODUCER SYSTEM

K904475 is an FDA 510(k) clearance for ENTREE SHEATH INTRODUCER SYSTEM, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K904475 · Cordis Corp. · Cardiovascular device
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Apr 1991
Decision
182d
Days
Class 2
Risk

K904475 is an FDA 510(k) clearance for the ENTREE SHEATH INTRODUCER SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 182 days - an extended review 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K904475

510(k) Number K904475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date April 01, 1991
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K904475.
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · Olympus Corp. · Jun 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · Cordis Corp. · May 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · Daig Corp. · May 1991
PERCUTANEOUS INTRODUCERS
K903530 · Davol, Inc. · Oct 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · Datascope Corp. · Oct 1990
PERCUTANEOUS INTRODUCER SET
K902275 · Thomas Medical Products, Inc. · Sep 1990