The following data is part of a premarket notification filed by Edwards Lifeciences, Llc with the FDA for Truwave Disposable Pressure Transducer.
| Device ID | K183413 |
| 510k Number | K183413 |
| Device Name: | TruWave Disposable Pressure Transducer |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Edwards Lifeciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Ye Seul Kim |
| Correspondent | Ye Seul Kim Edwards Lifeciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-10 |
| Decision Date | 2019-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 57460691949282 | K183413 | 000 |
| 57460691947462 | K183413 | 000 |
| 57460691947240 | K183413 | 000 |
| 57460691947226 | K183413 | 000 |
| 57460691924951 | K183413 | 000 |
| 57460691924845 | K183413 | 000 |