Cleared Special

K083402 - AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

K083402 is an FDA 510(k) clearance for AGILIS NXT STEERABLE INTRODUCER, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 27-day FDA review.

K083402 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
27d
Days
Class 2
Risk

K083402 is an FDA 510(k) clearance for the AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323. 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 December 15, 2008 after a review of 27 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.

FDA 510(k) Submission Details - K083402

510(k) Number K083402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2008
Decision Date December 15, 2008
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 706
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K083402.
THE WAND MICROACCESS SAFETY INTRODUCER
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K083855 · Acumen Medical, Inc. · Feb 2009
CROSSOVER
K083269 · Thomas Medical Products, Inc. · Feb 2009
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · St Jude Medical · Dec 2008
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K082580 · Spectra Medical Devices, Inc. · Dec 2008
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
K081697 · Access Scientific, Inc. · Dec 2008
K083402 · AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
Download PDF FDA Summary St Jude Medical