Cleared Traditional

K092575 - ENGAGE/ENGAGE TR

K092575 is the FDA 510(k) clearance for ENGAGE/ENGAGE TR by St Jude Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K092575 · St Jude Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2009
Decision
48d
Days
Class 2
Risk

K092575 is an FDA 510(k) clearance for the ENGAGE/ENGAGE TR. 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 October 8, 2009 after a review of 48 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 K092575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2009
Decision Date October 08, 2009
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 396
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K092575.
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MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · Oscor, Inc. · Jun 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · Terumo Medical Corp. · May 2009