Cleared Traditional

K083814 - OUTBACK LTD RE-ENTRY CATHETER

K083814 is an FDA 510(k) clearance for OUTBACK LTD RE-ENTRY CATHETER, manufactured by Cordis Corp., A Johnson & Johnson Co.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 22-day FDA review.

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

FDA 510(k) Submission Details - K083814

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.

PDU Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K083814.
WILDCAT CATHETER
K111338 · Avinger, Inc. · Aug 2011
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · Baylis Medical Co., Inc. · Jul 2010
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