RenovoCath - The RenovoCath is a multi-lumen, dual-balloon - Renovorx, Inc.

Duns Number:057757944

Device Description: The RenovoCath is a multi-lumen, dual-balloon catheter having a two-part handle that is de 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.

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More Product Details

Catalog Number

MMRC120-DB-1111

Brand Name

RenovoCath

Version/Model Number

009003 rev 4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191606,K212324

Product Code Details

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Device Record Status

Public Device Record Key

a0b9f5d1-13e7-4901-99f9-11c4ef7da407

Public Version Date

September 13, 2022

Public Version Number

5

DI Record Publish Date

November 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RENOVORX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1