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 |