The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Swan-ganz Heparin Coated, Etc. Catheter.
| Device ID | K811411 |
| 510k Number | K811411 |
| Device Name: | SWAN-GANZ HEPARIN COATED, ETC. CATHETER |
| Classification | Probe, Thermodilution |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-19 |
| Decision Date | 1981-06-12 |