Product code PRC
- Device name
- Drug-Coated Peripheral Transluminal Angioplasty Catheter
- 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
- Ineligible
- Definition
- Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P190008S049 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2026-05-21 |
| P190008S048 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2026-05-01 |
| P190008S047 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2026-04-23 |
| P190008S046 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2026-02-13 |
| P190008S038 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2026-01-30 |
| P190008S045 | IN.PACT AV Paclitaxel-coated PTA Balloon Catheter | Medtronic Vascular, Inc. | 2025-09-16 |
| P170003S028 | Lutonix 018 (Model 9014) | Lutonix | 2025-09-04 |
| P190008S044 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2025-08-12 |
| P190008S043 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-07-15 |
| P190008S041 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-07-10 |
| P190008S042 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2025-07-09 |
| P190008S040 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-07-09 |
| P190008S039 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-05-29 |
| P190008S036 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-03-26 |
| P190008S037 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2025-01-24 |
| P190008S033 | IN.PACT AV DCB | Medtronic Vascular, Inc. | 2024-12-03 |
| P190008S035 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2024-11-22 |
| P190008S034 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2024-10-21 |
| P170003S026 | Lutonix Drug Coated Balloon PTA Catheter | Lutonix | 2024-08-29 |
| P190008S030 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2024-06-27 |
| P190008S029 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2024-05-08 |
| P190008S028 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon | Medtronic Vascular, Inc. | 2024-04-23 |
| P190008S027 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter | Medtronic Vascular, Inc. | 2023-10-12 |
| P190008S025 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon | Medtronic Vascular, Inc. | 2023-09-14 |
| P170003S027 | Lutonix Drug Coated Balloon PTA Catheter | Lutonix | 2023-09-07 |
| P190008S026 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2023-08-30 |
| P190008S024 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic Vascular, Inc. | 2023-05-22 |
| P190008S023 | IN.PACT AV DCB | Medtronic Vascular, Inc. | 2023-05-04 |
| P190008S022 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2022-12-01 |
| P190008S021 | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | 2022-11-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00801741177217 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-09 |
| 00801741177187 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-08 |
| 00801741177170 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-08 |
| 00801741176975 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177163 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177156 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177149 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177125 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177095 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177071 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177064 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177040 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177033 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177026 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177019 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741176999 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741176951 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177088 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-10-04 |
| 00801741177477 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-05-30 |
| 00801741177453 | LUTONIX ® Drug Coated Balloon | LUTONIX, INC. | 2019-05-30 |
| 00801741177309 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177323 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177385 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177392 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177446 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177231 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-29 |
| 00801741177354 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-11 |
| 00801741177415 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-11 |
| 00801741177439 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-11 |
| 00801741177279 | LUTONIX® Drug Coated Balloon | LUTONIX, INC. | 2019-01-10 |