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 |