Cleared Traditional

AGILIS NXT STEERABLE INTRODUCER (K083083) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083083 · St Jude Medical · Cardiovascular device
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Nov 2008
Decision
21d
Days
Class 2
Risk

K083083 is an FDA 510(k) clearance for the AGILIS NXT 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 November 6, 2008 after a review of 21 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St Jude Medical devices

Submission Details

510(k) Number K083083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date November 06, 2008
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 217
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K083083.
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PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004