The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis 5.0 French Super Torque Catheters.
Device ID | K915836 |
510k Number | K915836 |
Device Name: | CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Katherine Trevisol |
Correspondent | Katherine Trevisol 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 | 1991-12-24 |
Decision Date | 1992-02-11 |