| Device Classification Name |
Mechanical Thrombolysis Catheter
|
| 510(k) Number |
K260149 |
| Device Name |
Versus™ Catheter (VS110-9NB) |
| Applicant |
| Liquet Medical, Inc. |
| 5619 Country Hills Ln. |
|
Glen Allen,
VA
23059
|
|
| Applicant Contact |
John Schnidler |
| Correspondent |
| Evergreen Strategic Consulting |
| 108 N Rolling Rd. |
|
Catonsville,
MD
21228
|
|
| Correspondent Contact |
Carrie Kuehn |
| Regulation Number | 870.5150 |
| Classification Product Code |
|
| Date Received | 01/20/2026 |
| Decision Date | 02/17/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|