RenovoCath MMRC120-DB-1111
GUDID 00851994005003
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.
Renovorx, Inc.
Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided| Primary Device ID | 00851994005003 |
| NIH Device Record Key | a0b9f5d1-13e7-4901-99f9-11c4ef7da407 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RenovoCath |
| Version Model Number | MMRC120-DB-1111 |
| Catalog Number | MMRC120-DB-1111 |
| Company DUNS | 057757944 |
| Company Name | Renovorx, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
| Guidewire Diameter | 0.014 Inch |
| Introducer Sheath Compatibilit | 6 French |
| Catheter Working Length | 86 Centimeter |
| Outer Diameter | 0.076 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851994005003 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191606
FDA Product Code
| MJN | Catheter, Intravascular Occluding, Temporary |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-10-29 |
| Device Publish Date | 2020-11-19 |
Trademark Results [RenovoCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENOVOCATH 85956593 4689326 Live/Registered |
Renovorx 2013-06-11 |
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