Cleared Traditional

OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 (K083814) - FDA 510(k) Clearance

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

K083814 · Cordis Corp., A Johnson & Johnson Co. · Cardiovascular device
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Jan 2009
Decision
22d
Days
Class 2
Risk

K083814 is an FDA 510(k) clearance for the OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Cordis Corp., A Johnson & Johnson Co. (Warren, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Cordis Corp., A Johnson & Johnson Co. devices

Submission Details

510(k) Number K083814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date January 13, 2009
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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 - PDU Catheter For Crossing Total Occlusions

All 24
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K083814.
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · Medtronic Vascular · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008
PIONEER PLUS CATHETER
K081804 · Medtronic, Inc. · Aug 2008
PIONEER CATHETER
K072155 · Medtronic, Inc. · Oct 2007