Cleared Special

K983023 - MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K983023 is an FDA 510(k) clearance for MODIFICATION TO CORDIS BRITE TIP CATHET..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 31-day FDA review.

K983023 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
31d
Days
Class 2
Risk

K983023 is an FDA 510(k) clearance for the MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on October 1, 1998 after a review of 31 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K983023

510(k) Number K983023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1998
Decision Date October 01, 1998
Days to Decision 31 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 648
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K983023.
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
K982797 · Luther Medical Products, Inc. · Nov 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
K981909 · Baxter Edwards · Nov 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · Daig Corp. · Sep 1998
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
K980578 · Innerdyne, Inc. · Sep 1998
CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
K982740 · Cordis Webster, Inc. · Aug 1998