The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Soft-vu And Mariner Angiographic Catheters.
Device ID | K173762 |
510k Number | K173762 |
Device Name: | AngioDynamics, Inc. Soft-Vu And Mariner Angiographic Catheters |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
Contact | Teri Juckett |
Correspondent | Teri Juckett AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-11 |
Decision Date | 2018-07-18 |
Summary: | summary |