Cleared Traditional

K091137 - ULTIMUM/ENGAGE/ENGAGE TR

K091137 is the FDA 510(k) clearance for ULTIMUM/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 2-day FDA review.

K091137 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
2d
Days
Class 2
Risk

K091137 is an FDA 510(k) clearance for the ULTIMUM/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 April 22, 2009 after a review of 2 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 K091137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date April 22, 2009
Days to Decision 2 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
123d faster than avg
Panel avg: 125d · This submission: 2d
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

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