The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Swan-ganz Catheters.
| Device ID | K193466 |
| 510k Number | K193466 |
| Device Name: | Swan-Ganz Catheters |
| Classification | Catheter, Flow Directed |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Anne Lo |
| Correspondent | Anne Lo Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DYG |
| Subsequent Product Code | DQE |
| Subsequent Product Code | DQO |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103198645 | K193466 | 000 |
| 50690103198558 | K193466 | 000 |
| 50690103198565 | K193466 | 000 |
| 50690103198435 | K193466 | 000 |
| 00690103198515 | K193466 | 000 |
| 00690103198539 | K193466 | 000 |
| 00690103198577 | K193466 | 000 |
| 00690103198584 | K193466 | 000 |
| 50690103198626 | K193466 | 000 |
| 00690103198638 | K193466 | 000 |
| 50690103198459 | K193466 | 000 |