B. Braun Interventional Systems
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2382-2015 | Class II | Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (C | June 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters | June 12, 2017 |
| K152765 | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM | February 26, 2016 |
| K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | April 2, 2013 |