510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160067Substantially Equivalent

RenovoCath

RenovoRx, Inc., Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160067 is the FDA 510(k) clearance record for RenovoCath, a class II device, cleared for Renovorx, Inc. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 4 510(k) clearances for Renovorx, Inc., from to . As of , FDA records show no recalls naming K160067.

Clearance record

Decision date
Received
(419 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Renovorx, Inc. 4546 El Camino Real, Suite 282, Los Altos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJN

Trailing 12 months

FDA records hold no clearances under product code MJN in the trailing twelve months.

FDA records show no clearances under product code MJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260