RenovoCath

FDA 510(k) K160067 · Renovorx, Inc.

Substantially Equivalent

510(k) numberK160067

Submission

Device name
RenovoCath
Applicant
Renovorx, Inc.
Los Altos, CA, US
Received
January 13, 2016
Decision date
March 7, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MJN – Catheter, Intravascular Occluding, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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K212324RenovoCathMJN · Special Renovorx, Inc.08/23/2021SE
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K210358Neurescue deviceMJN · Traditional Neurescue Aps05/21/2021SE
K201652COBRA-OS KitMJN · Traditional Front Line Medical Technologies, Inc.02/22/2021SESK
K203540Bridge Occlusion BalloonMJN · Special Spectranetics, Inc.12/23/2020SE

More from Spectranetics, Inc.

510(k)DeviceDecision
K212324RenovoCathMJN · Special 08/23/2021SE
K191606RenovoCathMJN · Traditional 08/07/2019SE
K141175Renovocath RC120MJN · Traditional 10/24/2014SE

Questions and answers

When was RenovoCath cleared by the FDA?

RenovoCath (K160067) received a 510(k) decision of Substantially Equivalent on March 7, 2017, 419 days after the submission was received.

What is the product code of K160067?

The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.