RenovoCath

Primary DI
00851994005003
Brand
RenovoCath
Company
Renovorx, Inc.
Model
009003 rev 4
Catalog number
MMRC120-DB-1111
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.
Published
2020-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191606000
K212324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191606000RenovoCathRenovorx, Inc.2019-08-07MJN
K212324000RenovoCathRenovorx, Inc.2021-08-23MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851994005003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851994005003008519940050038519940050030851994005003

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA 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 malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length86Centimeter
Guidewire Diameter0.014Inch
Introducer Sheath Compatibilit6French
Outer Diameter0.076Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
16502844433customerservice@renovorx.com

Regulatory Flags#

DUNS number
057757944
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
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00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
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10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
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10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
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20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
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00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03