Cleared Traditional

EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET (K980504) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980504 · Schneider/Namic · Cardiovascular device
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Aug 1998
Decision
179d
Days
Class 2
Risk

K980504 is an FDA 510(k) clearance for the EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET. 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 August 7, 1998 after a review of 179 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 Schneider/Namic devices

Submission Details

510(k) Number K980504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date August 07, 1998
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K980504.
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K974448 · Cordis Corp. · Feb 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · Cordis Corp. · Oct 1996