The following data is part of a premarket notification filed by Edwards Lifesiences, Llc with the FDA for Swang-ganz Iq Pulmonary Artery Catheter.
| Device ID | K222117 |
| 510k Number | K222117 |
| Device Name: | Swang-Ganz IQ Pulmonary Artery Catheter |
| Classification | Catheter, Flow Directed |
| Applicant | Edwards Lifesiences, LLC 1 Edwards Way Irvine, CA 92614 |
| Contact | Michelle Ducca |
| Correspondent | Michelle Ducca Edwards Lifesiences, LLC 1 Edwards Way Irvine, CA 92614 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-12-09 |