Cleared Special

MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 (K031583) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031583 · Integrated Vascular Systems, Inc. · Cardiovascular device
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Jun 2003
Decision
26d
Days
Class 2
Risk

K031583 is an FDA 510(k) clearance for the MODIFICATION TO IVS INTRODUCER SET, MODEL 1003. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Integrated Vascular Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 16, 2003 after a review of 26 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 Integrated Vascular Systems, Inc. devices

Submission Details

510(k) Number K031583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date June 16, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 222
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K031583.
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · Boston Scientific Corp · Jan 2004
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · Merit Medical Systems, Inc. · Oct 2003
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc. · Jan 2001
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000
IN-LINE HEMOSTASIS VALVE
K990975 · Merit Medical Systems, Inc. · Mar 2000