Cleared Traditional

K983039 - EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF

K983039 is an FDA 510(k) clearance for EMCEE INFUSION INTRODUCER SHEATH, manufactured by Schneider/Namic. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K983039 · Schneider/Namic · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
249d
Days
Class 2
Risk

K983039 is an FDA 510(k) clearance for the EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCE.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Schneider/Namic (Glens Falls, US). The FDA issued a Cleared decision on May 7, 1999 after a review of 249 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.

FDA 510(k) Submission Details - K983039

510(k) Number K983039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 31, 1998
Decision Date May 07, 1999
Days to Decision 249 days
Submission Type Traditional
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
124d slower than avg
Panel avg: 125d · This submission: 249d
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 685
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K983039.
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · Boston Scientific Corp · Oct 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · Adam Spence Corp. · Jul 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
K990705 · Medamicus, Inc. · Jun 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
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
K983039 · EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
Download PDF FDA Summary Schneider/Namic