Cleared Traditional

K214060 - LANDMARK REBOA Catheter (FDA 510(k) Clearance)

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

K214060 · Zien Medical Technologies, Inc. · Cardiovascular device
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Sep 2022
Decision
266d
Days
Class 2
Risk

K214060 is an FDA 510(k) clearance for the LANDMARK REBOA Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Zien Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2022 after a review of 266 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 Zien Medical Technologies, Inc. devices

Submission Details

510(k) Number K214060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date September 19, 2022
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
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 K214060.
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
RenovoCath
K212324 · Renovorx, Inc. · Aug 2021
AortaSTAT Occlusion Device
K210602 · Renalpro Medical, Inc. · Jul 2021