Cerenovus, Inc.
Medical device manufacturer in Irvine, CA.
10510(k) clearances
1PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | 08/14/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | 08/13/2026SE |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetNRY · Special | 08/22/2025SE |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterQJP · Traditional | 10/16/2024SE |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…NRY · Traditional | 10/16/2024SE |
| K233982 | CEREGLIDE 92 Catheter SystemQJP · Special | 05/09/2024SE |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetNRY · Special | 01/17/2024SE |
| K230726 | CEREGLIDE 92 Intermediate CatheterQJP · Traditional | 11/29/2023SE |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY · Traditional | 03/09/2023SE |
| K221930 | CEREGLIDE 71 Intermediate CatheterQJP · Traditional | 03/09/2023SE |
PMA approvals
- P990040 Trufill N-Butyl Cyanoacrylate Liquid Embolic System · 09/25/2000 · 36 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0434-2026 Class I | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM…Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke… | 10/02/2025Open, Classified |