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 |