The following data is part of a premarket notification filed by Intravent Medical Partners, Lp with the FDA for Solopass System.
| Device ID | K203251 |
| 510k Number | K203251 |
| Device Name: | SOLOPASS System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | inTRAvent Medical Partners, LP 421 W. Chocolate Ave. Hershey, PA 17036 |
| Contact | Adam Barner |
| Correspondent | Connie Qiu M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2021-08-27 |