The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 5 Fr And 6 Fr Infiniti Angiographic Catheter.
Device ID | K970854 |
510k Number | K970854 |
Device Name: | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Elena S Jugo |
Correspondent | Elena S Jugo CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-10 |
Decision Date | 1997-09-30 |
Summary: | summary |