Cleared Traditional

K103083 - AGILIS ES STEERABLE INTRODUCER

K103083 is an FDA 510(k) clearance for AGILIS ES STEERABLE INTRODUCER, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K103083 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
171d
Days
Class 2
Risk

K103083 is an FDA 510(k) clearance for the AGILIS ES STEERABLE INTRODUCER. 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 April 8, 2011 after a review of 171 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.

FDA 510(k) Submission Details - K103083

510(k) Number K103083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date April 08, 2011
Days to Decision 171 days
Submission Type Traditional
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
46d slower than avg
Panel avg: 125d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 706
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K103083.
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · St Jude Medical · Jun 2011
AFX INTRODUCER SYSTEM
K110090 · Endologix, Inc. · May 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · St Jude Medical · May 2011
TORFLEX TRANSSEPTAL GUIDING SHEATH
K102948 · Baylis Medical Co., Inc. · Apr 2011
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K101422 · Access Scientific, Inc. · Mar 2011
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
K100799 · Contract Medical Intl. GmbH · Feb 2011
K103083 · AGILIS ES STEERABLE INTRODUCER
Download PDF FDA Summary St Jude Medical