The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Truwave Disposable Pressure Transducer.
Device ID | K142749 |
510k Number | K142749 |
Device Name: | TruWave Disposable Pressure Transducer |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92641 |
Contact | Andrew S. Mazurkiewicz |
Correspondent | Andrew S. Mazurkiewicz EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92641 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-24 |
Decision Date | 2015-01-18 |
Summary: | summary |