The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Swan-ganz Flow-directed Catheter.
| Device ID | K791183 |
| 510k Number | K791183 |
| Device Name: | SWAN-GANZ FLOW-DIRECTED CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Sally L Maher |
| Correspondent | Sally L Maher EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-25 |
| Decision Date | 1979-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103147315 | K791183 | 000 |