Miami, FL, US · 10 510(k) clearances · 8 PMAs · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | Class II | Cardiovascular | 5 | 2026-08-13 |
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | 4 | 2024-10-16 |
| HCG | Device, Neurovascular Embolization | Class II | Neurology | 1 | 2026-08-14 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-05-26 | P990040-S038 | TRUFILL n-BCA Liquid Embolic System | 30-Day Notice | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2025-12-16 | P990040-S034 | TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set | Panel Track | SGU | Neurovascular Liquid Embolic Agent | Unknown |
| 2025-08-22 | P990040-S036 | TRUFILL n-BCA Liquid Embolic System | 30-Day Notice | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2025-05-28 | P990040-S035 | TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set | 30-Day Notice | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2024-07-02 | P990040-S033 | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System | Normal 180 Day Track | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2024-02-13 | P990040-S032 | TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set | 30-Day Notice | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2023-09-29 | P990040-S031 | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System | Normal 180 Day Track | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| 2023-02-28 | P990040-S030 | TRUFILL n-BCA Liquid Embolic System | Normal 180 Day Track No User Fee | KGG | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-02 | Class I | Ongoing | Z-0434-2026 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM… | — | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical interv… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-14 | K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | HCG | Class II | Neurology |
| 2026-08-13 | K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | NRY | Class II | Cardiovascular |
| 2025-08-22 | K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2024-10-16 | K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | QJP | Class II | Cardiovascular |
| 2024-10-16 | K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2024-05-09 | K233982 | CEREGLIDE 92 Catheter System | QJP | Class II | Cardiovascular |
| 2024-01-17 | K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2023-11-29 | K230726 | CEREGLIDE 92 Intermediate Catheter | QJP | Class II | Cardiovascular |
| 2023-03-09 | K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2023-03-09 | K221930 | CEREGLIDE 71 Intermediate Catheter | QJP | Class II | Cardiovascular |