Cleared Special

K042623 - AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304

K042623 is an FDA 510(k) clearance for AGILIS STEERABLE CATHETER INTRODUCER, manufactured by St. Jude Medical, Daig Division, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 122-day FDA review.

K042623 · St. Jude Medical, Daig Division, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042623

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 695
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K042623.
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
CATHETER INTRODUCER
K043525 · Galt Medical Corp. · Feb 2005
MODIFIED ACUMEN SHEATH, MODEL TTWO767
K050015 · Acumen Medical, Inc. · Feb 2005
MODIFICATION TO SHORT INTRODUCER SHEATH
K042399 · Rex Medical, L.P. · Dec 2004
ENPATH SAFETY INTRODUCER
K041708 · Enpath Medical Incorporated · Nov 2004
ACUMEN SHEATH, MODEL TTW7807
K042376 · Acumen Medical, Inc. · Oct 2004
K042623 · AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
Download PDF FDA Summary St. Jude Medical, Dai…