The following data is part of a premarket notification filed by Vascular Solutions Zerusa Ltd. with the FDA for Guardian Ii Hemostasis Valve Guardian Ii Nc Hemostasis Valve.
| Device ID | K122301 |
| 510k Number | K122301 |
| Device Name: | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | VASCULAR SOLUTIONS ZERUSA LTD. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS ZERUSA LTD. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-09-07 |
| Summary: | summary |