The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angioflow.
| Device ID | K854910 |
| 510k Number | K854910 |
| Device Name: | ANGIOFLOW |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Richard P Mohr |
| Correspondent | Richard P Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-09 |
| Decision Date | 1986-07-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANGIOFLOW 86443344 not registered Dead/Abandoned |
Optovue, Inc. 2014-11-03 |
![]() ANGIOFLOW 76488737 2877916 Dead/Cancelled |
AngioDynamics, Inc. 2003-02-10 |
![]() ANGIOFLOW 73582075 not registered Dead/Abandoned |
ANGIOMED GMBH INSTRUMENTE FUR DIE MEDIZINISCHE DIAGNOSTIK 1986-02-10 |