The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Super Torque Mb Angiographic Catheter With Radiopaque Marker Bands.
Device ID | K992347 |
510k Number | K992347 |
Device Name: | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | CORDIS CORP. 40 TECHNOLOGY DR. Warren, NJ 07059 |
Contact | Karen Wilk |
Correspondent | Karen Wilk CORDIS CORP. 40 TECHNOLOGY DR. Warren, NJ 07059 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-14 |
Decision Date | 1999-10-08 |
Summary: | summary |