Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list RenovoRx with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 23, 2021: RenovoCath.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 23, 2021 | RenovoCathK212324 · MJN | 510(k) clearances |
| Aug 7, 2019 | RenovoCathK191606 · MJN | 510(k) clearances |
| Mar 7, 2017 | RenovoCathK160067 · MJN | 510(k) clearances |
| Nov 25, 2015 | RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RClass II · Incorrect version of Instructions for Use were shipped to two US customers. | Device recalls |
| Oct 24, 2014 | RENOVOCATH RC120K141175 · MJN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
