The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Radar Vascular Compression Devices.
Device ID | K092503 |
510k Number | K092503 |
Device Name: | RADAR VASCULAR COMPRESSION DEVICES |
Classification | Clamp, Vascular |
Applicant | ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
Contact | Matthew Semler |
Correspondent | Matthew Semler ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-14 |
Decision Date | 2009-11-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20815614020115 | K092503 | 000 |
20815614020849 | K092503 | 000 |
20815614020092 | K092503 | 000 |