Product code NIM
- Device name
- Stent, Carotid
- 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, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P240009S008 | Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2026-05-08 |
| P060001S057 | Protégé™ GPS™ Self-Expanding Peripheral Stent System; Protégé™ RX Carotid Stent System | Medtronic Vascular, Inc. | 2026-03-23 |
| P040038S051 | XACT™ Carotid Stent System | Abbott Vascular, Inc. | 2026-03-20 |
| P240029S002 | CGuard™ Prime Carotid Stent System | InspireMD, Ltd. | 2026-03-16 |
| P240029S001 | CGuard™ Prime Carotid Stent System | InspireMD, Ltd. | 2026-02-20 |
| P060001S055 | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2026-02-20 |
| P060001S056 | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2026-02-11 |
| P240009S007 | Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2026-01-28 |
| P060001S054 | Protégé RX Carotid Stent System | Medtronic Vascular, Inc. | 2026-01-23 |
| P140026S033 | ENROUTE Transcarotid Stent System | Boston Scientific Corporation | 2026-01-08 |
| P030047S053 | PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System | Cordis US Corporation | 2026-01-08 |
| P060001S053 | Protégé™ GPS™ Self-expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2025-12-16 |
| P040038S048 | XACT® Carotid Stent System | Abbott Vascular, Inc. | 2025-12-09 |
| P060001S052 | Protégé GPS self-expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2025-11-07 |
| P140026S032 | ENROUTE® Transcarotid Stent System | Boston Scientific Corporation | 2025-10-23 |
| P040012S066 | RX Acculink | Abbott Vascular | 2025-10-22 |
| P030047S052 | PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System | Cordis US Corporation | 2025-10-21 |
| P040038S050 | XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) | Abbott Vascular, Inc. | 2025-10-17 |
| P240009S005 | Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection – (Neuroguard I | Contego Medical, Inc. | 2025-09-19 |
| P050019S043 | Carotid Wallstent™ Monorail™ Endoprosthesis | Boston Scientific Corp | 2025-09-19 |
| P030047S051 | PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System | Cordis US Corporation | 2025-09-12 |
| P040038S049 | XACT Carotid Stent System | Abbott Vascular, Inc. | 2025-08-25 |
| P240009S004 | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2025-08-22 |
| P060001S051 | Protege™ RX Carotid Stent System | Medtronic Vascular, Inc. | 2025-08-13 |
| P060001S050 | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2025-07-25 |
| P060001S049 | Protégé™ RX Carotid Stent System | Medtronic Vascular, Inc. | 2025-07-17 |
| P240029 | CGuard Prime Carotid Stent System | InspireMD, Ltd. | 2025-06-23 |
| P210030S001 | Roadsaver/CASPER Carotid Stent Device | MicroVention, Inc. | 2025-06-23 |
| P060001S047 | PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS | Medtronic Vascular, Inc. | 2025-05-09 |
| P060001S048 | Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System | Medtronic Vascular, Inc. | 2025-05-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811425020906 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024713 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024706 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024690 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024683 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024676 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024669 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425024652 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020944 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020937 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020920 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020913 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020890 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020883 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020876 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020869 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 00811425020852 | Roadsaver Carotid Atery Stent | Microvention, Inc. | 2025-08-01 |
| 07290120281707 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281905 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281936 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281943 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281974 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281981 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281899 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281783 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281776 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281745 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281738 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 07290120281691 | CGuard Prime Carotid Stent System | INSPIRE M.D LTD | 2025-07-02 |
| 08717648356704 | XACT™ | ABBOTT VASCULAR INC. | 2025-04-17 |