TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.
FDA premarket approval P990040/S021 · decided 2015-09-25
Approval details
- PMA number
- P990040
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.
- Generic name
- tissue adhesive for use in embolization of brain arteriovenous malformations
- Applicant
- Cerenovus, Inc.
- Date received
- 2015-08-28
- Decision date
- 2015-09-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- KGG
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS. REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (K251828) | Cerenovus, Inc. | 2025-08-22 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221) | Cerenovus, Inc. | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244) | Cerenovus, Inc. | 2024-10-16 |
| CEREGLIDE 92 Catheter System (K233982) | Cerenovus, Inc. | 2024-05-09 |
| Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (K233988) | Cerenovus, Inc. | 2024-01-17 |
| CEREGLIDE 92 Intermediate Catheter (K230726) | Cerenovus, Inc. | 2023-11-29 |
| CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) | Cerenovus, Inc. | 2023-03-09 |
| CEREGLIDE 71 Intermediate Catheter (K221930) | Cerenovus, Inc. | 2023-03-09 |