The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Radar Vascular Compression Device.
Device ID | K142122 |
510k Number | K142122 |
Device Name: | RADAR VASCULAR COMPRESSION DEVICE |
Classification | Clamp, Vascular |
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 | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-04 |
Decision Date | 2014-12-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20815614020085 | K142122 | 000 |
30815614020075 | K142122 | 000 |