Data / Medical devices / United States / Advanced Vascular Dynamics
Advanced Vascular Dynamics: FDA-registered device maker in Tigard, OR, United States, 16 510(k) clearances
Advanced Vascular Dynamics is registered with the FDA (registration 3032534) in Tigard, OR, United States. It lists 6 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 12, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032534
- FEI number
- 3002565916
- Address
- 8330 SW Hunziker Road, Tigard, OR, United States, 97223
- Owner or operator
- ADVANCED VASCULAR DYNAMICS (9035686)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 31, 2007
- Registered through
- 2026
- Brand names listed
- 3-Finger Jack, ArmBoard, ClampEase, Comfort, ComfortPress, Compass, CompressAR, CompressAR Universal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 12, 2018 | K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | QSY | Substantially Equivalent | Statguard, LLC | accessdata.fda.gov |
| July 31, 2015 | K151363 | Zephyr Vascular Compression Device | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| December 4, 2014 | K142122 | RADAR VASCULAR COMPRESSION DEVICE | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| November 19, 2009 | K092503 | RADAR VASCULAR COMPRESSION DEVICES | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| March 23, 2009 | K090286 | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| September 6, 2007 | K072167 | COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| March 10, 2006 | K053398 | COMPASS COMPRESSION ASSIST HANDLE | DXC | Substantially Equivalent | Semler Technologies, Inc. Dba | accessdata.fda.gov |
| June 1, 2004 | K040615 | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| September 27, 2000 | K002767 | COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE | DXC | Substantially Equivalent | Semler Technologies, Inc. | accessdata.fda.gov |
| December 11, 1997 | K964663 | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX | DXC | Substantially Equivalent | Rmds, Inc. | accessdata.fda.gov |
| August 8, 1997 | K970027 | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 | DXC | Substantially Equivalent | Rmds, Inc. | accessdata.fda.gov |
| February 3, 1997 | K964662 | FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 | DXC | Substantially Equivalent | Rmds, Inc. | accessdata.fda.gov |
| February 22, 1993 | K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM | DXC | Substantially Equivalent | Instromedix, Inc. | accessdata.fda.gov |
| May 19, 1989 | K891000 | MODIFIED EXTERNAL PAD | DWS | Substantially Equivalent | Instromedix, Inc. | accessdata.fda.gov |
| November 20, 1986 | K863427 | CLAMPEASE FA | DXC | Substantially Equivalent | Freund Medical Products | accessdata.fda.gov |
| July 19, 1983 | K831337 | COMPRESSAR DISPOSABLE DISC | DQO | Substantially Equivalent | Instromedix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Vascular
- All makers of Accessories, Catheter
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Restraint, Protective
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Catheter, Intravascular, Diagnostic
Updated April 12, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.