The following data is part of a premarket notification filed by Millimed A/s with the FDA for Easypass Us Y-connector Hemostatic Valve.
| Device ID | K042060 |
| 510k Number | K042060 |
| Device Name: | EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MILLIMED A/S 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Contact | Judith Danielson |
| Correspondent | Judith Danielson MILLIMED A/S 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2004-10-06 |
| Summary: | summary |