Product code MOU
- Device name
- Intravascular Radiation Delivery System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000018S051 | Novoste™ Beta-Cath™ System | Best Vascular, Inc. | 2024-09-26 |
| P000018S050 | Beta-Cath System | Best Vascular, Inc. | 2019-09-19 |
| P000018S048 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2017-07-13 |
| P000018S046 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2016-10-06 |
| P000018S047 | BETA-CATH (TM) SYSTEM | Best Vascular, Inc. | 2016-07-26 |
| P000018S045 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2011-11-04 |
| P000018S044 | BETA-CATH SYSTEM | Best Vascular, Inc. | 2011-02-23 |
| P000018S043 | BETA-CATH SYSTEM | Best Vascular, Inc. | 2008-11-19 |
| P000018S042 | BETA-CATH SYSTEM | Best Vascular, Inc. | 2006-06-16 |
| P000018S041 | NOVOSTE BETA - CATH SYSTEM | Best Vascular, Inc. | 2004-10-04 |
| P000052S025 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | 2004-06-10 |
| P000018S040 | NOVOSTE BETA-CATH 3.5F SYSTEM | Best Vascular, Inc. | 2004-06-10 |
| P000052S024 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | 2004-05-04 |
| P000052S023 | GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | 2004-03-16 |
| P000052S021 | GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS | Guidant Corp. | 2004-03-04 |
| P000018S035 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2004-02-17 |
| P000052S022 | GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS | Guidant Corp. | 2003-12-18 |
| P000018S039 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-11-18 |
| P000018S027 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-10-23 |
| P000018S038 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-10-14 |
| P000018S037 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-10-09 |
| P000018S036 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-10-09 |
| P000052S020 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | 2003-09-03 |
| P000052S019 | GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS | Guidant Corp. | 2003-07-24 |
| P000018S029 | NOVOSTE BETA-CATH 3.5F SYSTEM | Best Vascular, Inc. | 2003-07-18 |
| P000052S016 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | 2003-06-27 |
| P000018S034 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-06-25 |
| P000018S028 | BETA-CATH 3.5F SYSTEM - 60 MM | Best Vascular, Inc. | 2003-06-25 |
| P000018S033 | NOVOSTE BETA-CATH SYSTEM | Best Vascular, Inc. | 2003-06-11 |
| P000052S017 | GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS | Guidant Corp. | 2003-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M097PAP00351 | Procedure Accessory Pack, 3.5F Coronary System, 5-Pack | BEST VASCULAR, INC. | 2016-06-22 |
| M0975301770020 | Accessories Kit | BEST VASCULAR, INC. | 2015-09-10 |
| M097ABR03460 | B-Rail 3.5F Delivery Catheter | BEST VASCULAR, INC. | 2015-09-10 |
| M097BRX03460 | B-Rail 3.5F XL Delivery Catheter | BEST VASCULAR, INC. | 2015-09-10 |
| M097MPK00021 | Medical Physicist Kit | BEST VASCULAR, INC. | 2015-09-10 |
| M097PAP00350 | Procedure Accessory Pack | BEST VASCULAR, INC. | 2015-09-10 |
| M097RSK00020 | Novoste Response Kit | BEST VASCULAR, INC. | 2015-09-10 |
| M097TDA20300 | Alpha VI 30mm Transfer Device | BEST VASCULAR, INC. | 2015-09-10 |
| M097TDA20400 | Alpha VI 40mm Transfer Device | BEST VASCULAR, INC. | 2015-09-10 |
| M097TDA20600 | Alpha VI 60mm Transfer Device | BEST VASCULAR, INC. | 2015-09-10 |
| M097TRC00020 | Twin Transport Case | BEST VASCULAR, INC. | 2015-09-10 |
| M097TSC00010 | Temporary Storage Container | BEST VASCULAR, INC. | 2015-09-10 |