Cleared Special

K081645 - AGILIS NXT STEERABLE INTRODUCER

K081645 is the FDA 510(k) clearance for AGILIS NXT STEERABLE INTRODUCER by St Jude Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 180-day FDA review.

K081645 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
180d
Days
Class 2
Risk

K081645 is an FDA 510(k) clearance for the AGILIS NXT STEERABLE INTRODUCER, MODEL G408324. 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 9, 2008 after a review of 180 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. 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 devices

Submission Details

510(k) Number K081645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date December 09, 2008
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 K081645.
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · Terumo Medical Corp. · May 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · St Jude Medical · Apr 2009
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · St Jude Medical · Dec 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · St Jude Medical · Nov 2008
PINNACLE ROII INTRODUCER SHEATH
K082847 · Terumo Medical Corp. · Oct 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008