Integra Lifesciences Production Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | August 8, 2025 |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (82 | August 6, 2025 |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | February 4, 2024 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | January 17, 2024 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | December 19, 2023 |
| K223330 | Certas Plus Programmable Valves | February 1, 2023 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | October 14, 2022 |
| K210993 | CereLink ICP Monitor | April 30, 2021 |