The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Ptca Guiding Cather.
| Device ID | K844161 |
| 510k Number | K844161 |
| Device Name: | PTCA GUIDING CATHER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Donna L Rogers |
| Correspondent | Donna L Rogers CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-01-02 |