Bolton Medical Inc.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1383-2024 | Class II | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and pati | February 22, 2024 |
| Z-1689-2023 | Class II | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main | May 3, 2023 |
| Z-0998-2023 | Class II | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX | December 20, 2022 |
| Z-0997-2023 | Class II | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | December 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K021996 | BOLTON PTA CATHETER | August 23, 2002 |