Cleared Traditional

K083269 - CROSSOVER

K083269 is the FDA 510(k) clearance for CROSSOVER by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K083269 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
90d
Days
Class 2
Risk

K083269 is an FDA 510(k) clearance for the CROSSOVER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on February 3, 2009 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K083269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2008
Decision Date February 03, 2009
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 373
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K083269.
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
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, MODEL G408324
K081645 · St Jude Medical · Dec 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · St Jude Medical · Nov 2008