The following data is part of a premarket notification filed by Device Partners International with the FDA for Liisa Lever Integrated Interventional System Adapter, Model Vsl-109.
Device ID | K073260 |
510k Number | K073260 |
Device Name: | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | DEVICE PARTNERS INTERNATIONAL 4305 ENTERPRISE DRIVE SUITE E Winston-salem, NC 27106 |
Contact | Monica E Dougherty |
Correspondent | Monica E Dougherty DEVICE PARTNERS INTERNATIONAL 4305 ENTERPRISE DRIVE SUITE E Winston-salem, NC 27106 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-20 |
Decision Date | 2008-03-13 |
Summary: | summary |