Cerenovus Inc

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
8
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0434-2026Class ICEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCOctober 2, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetAugust 22, 2025
K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing October 16, 2024
K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterOctober 16, 2024
K233982CEREGLIDE 92 Catheter SystemMay 9, 2024
K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetJanuary 17, 2024
K230726CEREGLIDE 92 Intermediate CatheterNovember 29, 2023
K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetMarch 9, 2023
K221930CEREGLIDE 71 Intermediate CatheterMarch 9, 2023