The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Avd Right Radial Drape.
Device ID | K131571 |
510k Number | K131571 |
Device Name: | AVD RIGHT RADIAL DRAPE |
Classification | Drape, Surgical |
Applicant | ADVANCED VASCULAR DYNAMICS 4252 SE International Way Ste F Milwaukie, OR 97222 |
Contact | Matthew Semler |
Correspondent | Matthew Semler ADVANCED VASCULAR DYNAMICS 4252 SE International Way Ste F Milwaukie, OR 97222 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-30 |
Decision Date | 2014-01-31 |
Summary: | summary |