Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record P240029
Device name not on record · InspireMD, Ltd. · decided 2025-06-23 (APPR)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CGuard Prime Carotid Stent System | CND0940 | INSPIRE M.D LTD | NIM | 07290120281745 |
| CGuard Prime Carotid Stent System | CND0830 | INSPIRE M.D LTD | NIM | 07290120281691 |
| CGuard Prime Carotid Stent System | CND1030 | INSPIRE M.D LTD | NIM | 07290120281776 |
| CGuard Prime Carotid Stent System | CND0840 | INSPIRE M.D LTD | NIM | 07290120281707 |
| CGuard Prime Carotid Stent System | CND1040 | INSPIRE M.D LTD | NIM | 07290120281783 |
| CGuard Prime Carotid Stent System | CND0930 | INSPIRE M.D LTD | NIM | 07290120281738 |