RenovoRx, Inc.

FDA Regulatory Profile

RenovoRx, Inc. appears in FDA public data with 1 recall, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0565-2016, Class II) was initiated on November 25, 2015. Its most recent 510(k) clearance was granted on August 23, 2021.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0565-2016Class IIRenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx oNovember 25, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K212324RenovoCathAugust 23, 2021
K191606RenovoCathAugust 7, 2019
K160067RenovoCathMarch 7, 2017
K141175RENOVOCATH RC120October 24, 2014