The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Swan-ganz Flow-directed Multipur. Cath..
| Device ID | K803058 |
| 510k Number | K803058 |
| Device Name: | SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-02 |
| Decision Date | 1981-01-16 |