The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics Mariner Angiographic Catheters.
Device ID | K151724 |
510k Number | K151724 |
Device Name: | AngioDynamics Mariner Angiographic Catheters |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
Contact | Teri Juckett |
Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. 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 | 2015-06-26 |
Decision Date | 2015-10-14 |
Summary: | summary |