The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Ascendra Balloon Aortic Valvaloplasty Catheter.
| Device ID | K142199 |
| 510k Number | K142199 |
| Device Name: | Ascendra Balloon Aortic Valvaloplasty Catheter |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | EDWARDS LIFESCIENCES ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Susan Reynolds |
| Correspondent | Susan Reynolds EDWARDS LIFESCIENCES ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2014-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103191783 | K142199 | 000 |