Cleared Traditional

K002286 - LDOB OCCLUSION BALLOON CATHETER (FDA 510(k) Clearance)

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

K002286 · Cook, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
238d
Days
Class 2
Risk

K002286 is an FDA 510(k) clearance for the LDOB OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 22, 2001 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Cook, Inc. devices

Submission Details

510(k) Number K002286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2000
Decision Date March 22, 2001
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K002286.
pREBOA-PRO Catheter
K243795 · Prytime Medical Devices, Inc. · Sep 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · Philips Image Guided Therapy Devices · Jun 2025
preCARDIA Occlusion System
K221294 · Abiomed, Inc. · Jun 2023
Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022