Cleared Traditional

K160067 - RenovoCath

K160067 is an FDA 510(k) clearance for RenovoCath, manufactured by Renovorx, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K160067 · Renovorx, Inc. · Cardiovascular device
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Mar 2017
Decision
419d
Days
Class 2
Risk

K160067 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 March 7, 2017 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Renovorx, Inc. devices

FDA 510(k) Submission Details - K160067

510(k) Number K160067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2016
Decision Date March 07, 2017
Days to Decision 419 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
294d slower than avg
Panel avg: 125d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

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 Consultant

Experien Group, LLC
Ronald S. Warren

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MJN Catheter, Intravascular Occluding, Temporary

All 88
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K160067.
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K152833 · LeMaitre Vascular, Inc. · Jan 2016