The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Swan Ganz Catheters.
| Device ID | K160084 |
| 510k Number | K160084 |
| Device Name: | Swan Ganz Catheters |
| Classification | Catheter, Flow Directed |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Mugdha Dongre |
| Correspondent | Mugdha Dongre Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DYG |
| Subsequent Product Code | DQE |
| Subsequent Product Code | DQO |
| Subsequent Product Code | KRA |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-15 |
| Decision Date | 2016-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103197402 | K160084 | 000 |
| 00690103005134 | K160084 | 000 |
| 00690103003925 | K160084 | 000 |
| 00690103003109 | K160084 | 000 |
| 00690103003031 | K160084 | 000 |
| 00690103002881 | K160084 | 000 |
| 00690103002850 | K160084 | 000 |
| 00690103000566 | K160084 | 000 |
| 00690103000542 | K160084 | 000 |
| 00690103000504 | K160084 | 000 |
| 00690103000474 | K160084 | 000 |
| 00690103000467 | K160084 | 000 |
| 00690103000405 | K160084 | 000 |
| 00690103000375 | K160084 | 000 |
| 00690103000313 | K160084 | 000 |
| 00690103000276 | K160084 | 000 |
| 00690103000269 | K160084 | 000 |
| 00690103017236 | K160084 | 000 |
| 00690103017243 | K160084 | 000 |
| 00690103197396 | K160084 | 000 |
| 00690103197389 | K160084 | 000 |
| 00690103197358 | K160084 | 000 |
| 00690103197341 | K160084 | 000 |
| 00690103197327 | K160084 | 000 |
| 00690103197310 | K160084 | 000 |
| 00690103197303 | K160084 | 000 |
| 00690103161236 | K160084 | 000 |
| 00690103153132 | K160084 | 000 |
| 00690103151961 | K160084 | 000 |
| 00690103151756 | K160084 | 000 |
| 00690103146998 | K160084 | 000 |
| 00690103146554 | K160084 | 000 |
| 00690103018295 | K160084 | 000 |
| 00690103017830 | K160084 | 000 |
| 00690103017823 | K160084 | 000 |
| 00690103000245 | K160084 | 000 |