Cleared Traditional

RenovoCath (K191606) - FDA 510(k) Clearance

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

K191606 · Renovorx, Inc. · Cardiovascular device
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Aug 2019
Decision
51d
Days
Class 2
Risk

K191606 is an FDA 510(k) clearance for the RenovoCath. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Renovorx, Inc. (Los Altos, US). The FDA issued a Cleared decision on August 7, 2019 after a review of 51 days - a notably fast clearance 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: 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 Renovorx, Inc. devices

Submission Details

510(k) Number K191606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2019
Decision Date August 07, 2019
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 24
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K191606.
pREBOA-PRO Catheter
K200459 · Prytime Medical Devices, Inc. · Jun 2020
Gatekeeper Balloon Catheter
K192786 · Arch Catheter, LLC · Apr 2020
ER-REBOA PLUS Catheter
K193440 · Prytime Medical Devices, Inc. · Jan 2020
Eclipse 2L
K183045 · Balt USA, LLC · Apr 2019
Occlusion Balloon Catheter
K183679 · Qxmedical, LLC · Apr 2019
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916 · Lemaitre Vascular · Nov 2018