The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Swan-ganz Monitoring Catheter With Oligon Material.
| Device ID | K014054 |
| 510k Number | K014054 |
| Device Name: | EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason Smith |
| Correspondent | Jason Smith EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-03-08 |
| Summary: | summary |