Cleared Special

K984500 - CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K984500 is an FDA 510(k) clearance for CORDIS BRITE TIP CATHETER SHEATH INTROD..., 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 6-day FDA review.

K984500 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
6d
Days
Class 2
Risk

K984500 is an FDA 510(k) clearance for the 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 December 23, 1998 after a review of 6 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 - K984500

510(k) Number K984500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date December 23, 1998
Days to Decision 6 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
119d faster than avg
Panel avg: 125d · This submission: 6d
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 K984500.
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
K983039 · Schneider/Namic · May 1999
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
K984062 · Diag Corp. · Mar 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · Terumo Medical Corp. · Jan 1999
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
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · Cordis Corp. · Oct 1998