The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Truwave Disposable Pressure Transducer.
| Device ID | K141495 |
| 510k Number | K141495 |
| Device Name: | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Andrew S Mazurkiewicz, Jr |
| Correspondent | Andrew S Mazurkiewicz, Jr EDWARDS LIFESCIENCES, 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 | 2014-06-06 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103200343 | K141495 | 000 |
| 50690103200398 | K141495 | 000 |
| 50690103200381 | K141495 | 000 |
| 50690103200404 | K141495 | 000 |
| 50690103206055 | K141495 | 000 |
| 50690103197698 | K141495 | 000 |
| 50690103197681 | K141495 | 000 |
| 50690103200008 | K141495 | 000 |
| 50690103201791 | K141495 | 000 |
| 50690103204402 | K141495 | 000 |
| 50690103200282 | K141495 | 000 |
| 50690103200305 | K141495 | 000 |
| 50690103200312 | K141495 | 000 |
| 50690103200329 | K141495 | 000 |
| 50690103210311 | K141495 | 000 |