RenovoCath

Basic Information

Brand Name: RenovoCath
Primary DI: 00851994005003
Version / Model: 009003 rev 4
Catalog Number: MMRC120-DB-1111
Company Name: Renovorx, Inc.
Labeler DUNS: 057757944
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-11-19
Public Version: 6
Public Version Date: 2023-12-04
Public Version Status: Update
Public Device Record Key: a0b9f5d1-13e7-4901-99f9-11c4ef7da407

Device Description

The RenovoCath is a multi-lumen, dual-balloon catheter having a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The inflation of the proximal occlusion balloon and of the distal occlusion balloon may isolate the selected site prior to the infusion of fluids into the same site. The two balloons are inflated independently using diagnostic contrast agents delivered via two separate inflation lumens. The distance between the proximal occlusion balloon and the distal occlusion balloon is controlled by the operator. Radiopaque markers are located between the two balloons to allow for identification of target site and position adjustment under fluoroscopic guidance. The RenovoCath is supplied sterile, is for single use and is disposable.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32584	Intravascular occluding balloon catheter, image-guided	A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.	No	Active
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851994005003	GS1

Customer Contacts

Phone: 16502844433
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191606	000
K212324	000

Device Sizes

Type	Value	Unit
Guidewire Diameter	0.014	Inch
Introducer Sheath Compatibility	6	French
Catheter Working Length	86	Centimeter
Outer Diameter	0.076	Inch