Cleared Special

K081645 - AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

K081645 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 180-day FDA review.

K081645 · 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
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.

FDA 510(k) Submission Details - K081645

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.

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 K081645.
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K081645 · AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
Download PDF FDA Summary St Jude Medical