The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Edwards Lifesciences Left Atrial Pressure Monitor Catheter.
| Device ID | K110103 |
| 510k Number | K110103 |
| Device Name: | EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | EDWARDS LIFESCIENCES LLC 12050 LONE PEAK PARKWAY Draper, UT 84020 -0000 |
| Contact | Spencer Walker |
| Correspondent | Spencer Walker EDWARDS LIFESCIENCES LLC 12050 LONE PEAK PARKWAY Draper, UT 84020 -0000 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-13 |
| Decision Date | 2011-02-11 |
| Summary: | summary |