FDA.reportPublic FDA data

RENOVORX, INC.

Matched from indexed company URL: RENOVO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30112796743011279674RENOVORX, INC.1N2026-01-012570 W El Camino Suite 320 Mountain View CA US 94040
30140235453014023545RENOVO, INC.1N2026-01-01340 SW COLUMBIA ST Bend OR US 97702
30109819493010981949RENOVO LIFE LLC1N2020-04-251104 Spruce Street Belmont NC US 28012

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1764481152227410K212324RenovoCathMJN2021-08-23
1764481699725477K191606RenovoCathMJN2019-08-07
2114272030138206K173741Reprocessed ArthoCare Ablation WandNUJ2018-03-05
2114271143477685K173740Reprocessed DePuy Mitek Ablation WandNUJ2018-03-19
2114271178649201K172647Reprocessed ArthroCare ENT CoblatorNUJ2018-02-21
2114271352726919K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLM2017-10-06
2114271422744499K172093Reprocessed Covidien TrocarNLM2017-10-05
2114271579470534K172092Reprocessed Shavers/BursHRX2017-10-04
1723321641827706K161254Renovo Life Small Bone IM Nail SystemHSB2016-11-07
1723321134599896K151661Renovo Life Hard Carbon Coated Drill BitHTW2016-01-15
1764481191421130K141175RENOVOCATH RC120MJN2014-10-24
1723321916037287K102845MAHE FIXATION PLATE AND SCREW SYSTEMHRS2011-05-13
1723321000721815
1723321001245984
2114271009610732
1723321009908133
1723321013847774
2114271041288751
1723321054046469
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2114271990449278
2114272001390664
1723322015703838
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2114272019111218
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2114272006493969

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUJ62018-03-19
NLM42017-10-06
MJN32021-08-23
HRX22017-10-04
HSB12016-11-07
HTW12016-01-15
HRS12011-05-13

PMN#

GUDID#

RenovoCath - 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.

2020-11-19