The following data is part of a premarket notification filed by Zerusa Limited with the FDA for Guardian Hemostasis Valve With Guidewire Introducer.
| Device ID | K052381 |
| 510k Number | K052381 |
| Device Name: | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | ZERUSA LIMITED 219-220 BUSINESS INNOVATION CENTRE NUIG, NEWCASTLE RD Galway, IE |
| Contact | Oonagh Sweeney |
| Correspondent | Oonagh Sweeney ZERUSA LIMITED 219-220 BUSINESS INNOVATION CENTRE NUIG, NEWCASTLE RD Galway, IE |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-30 |
| Decision Date | 2005-11-21 |
| Summary: | summary |