Cleared Special

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 (K042623) - FDA 510(k) Clearance

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

K042623 · St. Jude Medical, Daig Division, Inc. · Cardiovascular device
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Jan 2005
Decision
122d
Days
Class 2
Risk

K042623 is an FDA 510(k) clearance for the AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St. Jude Medical, Daig Division, Inc. (Minnetonka, US). The FDA issued a Cleared decision on January 27, 2005 after a review of 122 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, Daig Division, Inc. devices

Submission Details

510(k) Number K042623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date January 27, 2005
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 217
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K042623.
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CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004
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K034061 · Boston Scientific Corp · Jan 2004
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K031922 · Merit Medical Systems, Inc. · Oct 2003