Cleared Special

K031906 - APEEL CS CATHETER DELIVERY SYSTEM

K031906 is the FDA 510(k) clearance for APEEL CS CATHETER DELIVERY SYSTEM by St Jude Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K031906 · St Jude Medical · Cardiovascular device
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Jul 2003
Decision
28d
Days
Class 2
Risk

K031906 is an FDA 510(k) clearance for the APEEL CS CATHETER DELIVERY SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 28 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 St Jude Medical devices

Submission Details

510(k) Number K031906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date July 18, 2003
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 396
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K031906.
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
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GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
SAFETY INTRODUCER NEEDLE
K030135 · B.Braun Medical, Inc. · Jul 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · Edwards Lifesciences, LLC · Jun 2003
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003