Product code NIN
- Device name
- Stent, Renal
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P110001S022 | RX Herculink Elite | Abbott Vascular | 2025-10-22 |
| P110001S021 | RX HERCULINK ELITE RENAL STENT SYSTEM | Abbott Vascular | 2025-07-02 |
| P060006S109 | Express® SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2023-12-12 |
| P060006S108 | Express SD Renal | Boston Scientific Corp | 2023-08-31 |
| P060006S107 | Express® SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2023-07-27 |
| P110001S020 | RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular | 2023-06-14 |
| P060006S106 | Express SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2023-03-08 |
| P060006S105 | Express SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2023-03-02 |
| P060006S104 | Express® SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2022-11-15 |
| P110001S018 | RX Herculink Elite Renal Stent System | Abbott Vascular | 2022-03-24 |
| P890017S022 | Cordis® PALMAZ® Balloon-Expandable Stent | Cordis US Corporation | 2022-03-08 |
| P060006S103 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2022-02-25 |
| P110001S017 | RX Herculink Elite Renal Stent System | Abbott Vascular | 2021-12-08 |
| P110001S016 | RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular | 2021-10-26 |
| P110001S015 | RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular | 2021-06-22 |
| P110001S014 | RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular | 2021-06-21 |
| P060006S102 | Express SD Renal Premounted Stent System | Boston Scientific Corp | 2020-11-18 |
| P060006S101 | Express SD Renal Premounted Stent System | Boston Scientific Corp | 2020-08-17 |
| P060006S100 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2020-05-19 |
| P060006S099 | Express SD Premounted Renal Stent System | Boston Scientific Corp | 2020-03-02 |
| P060006S098 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2019-11-07 |
| P890017S020 | PALMAZ Balloon Expandable Stent | Cordis US Corporation | 2019-08-21 |
| P060006S097 | BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM | Boston Scientific Corp | 2019-07-25 |
| P060006S096 | Express SD Premounted Stent System (ESD) | Boston Scientific Corp | 2019-06-18 |
| P060006S095 | Express SD Renal Monorail Premounted Stent System | Boston Scientific Corp | 2018-12-10 |
| P060006S094 | Express SD Renal Monorail Premounted System | Boston Scientific Corp | 2018-10-10 |
| P060006S093 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2018-09-19 |
| P060006S091 | Express SD Monorail Premounted Stent Systemt | Boston Scientific Corp | 2018-09-07 |
| P060006S092 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2018-07-11 |
| P060006S090 | Express SD Monorail Premounted Stent System | Boston Scientific Corp | 2018-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10827002566160 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566313 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566306 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566290 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566283 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566276 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566269 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566252 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566245 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566238 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566214 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566207 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566191 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566184 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566177 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002185231 | Formula | William Cook Europe ApS | 2014-09-24 |
| 10827002566153 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566146 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566139 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566115 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566108 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566092 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566078 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566061 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002566054 | Formula 418 | COOK INCORPORATED | 2014-09-24 |
| 10827002185286 | Formula | William Cook Europe ApS | 2014-09-24 |
| 10827002185279 | Formula | William Cook Europe ApS | 2014-09-24 |
| 10827002185262 | Formula | William Cook Europe ApS | 2014-09-24 |
| 10827002185255 | Formula | William Cook Europe ApS | 2014-09-24 |
| 10827002185248 | Formula | William Cook Europe ApS | 2014-09-24 |