SOLOPASS 2.0 System
Intravent Medical Partners
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021591288 | 3021591288 | INTRAVENT MEDICAL PARTNERS LP | 1 | N | 2026-01-01 | 1730 Walton Rd Ste 110 Blue Bell PA US 19422 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860012211906 | SOLOPASS 2.0 Patient Interface Device - A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter guide. | 999-999-9999 | quality@intraventmedical.com |
| 00860012211913 | SOLOPASS 2.0 Ultrasound Cable Assembly - Ultrasound Cable Assembly includes the probe tip, handle assembly and a connector. | 999-999-9999 | quality@intraventmedical.com |
| 00860012211920 | SOLOPASS 2.0 Workstation - Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy. | 999-999-9999 | quality@intraventmedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 302247 | 1266722025 | K251317 | SOLOPASS 2.0 System | HAW | 2025-09-05 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HAW | 1 | 2025-09-05 |
Intravent Medical Partners
InTRAvent Medical Partners, LP
2025-12-11
2025-12-11
2025-12-11