The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Edwards Balloon Catheter.
| Device ID | K153069 |
| 510k Number | K153069 |
| Device Name: | Edwards Balloon Catheter |
| Classification | Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter |
| Applicant | EDWARDS LIFESCIENCES 1 EDWARDS WAY Irvine, CA 92614 |
| Contact | Chris Kennelly |
| Correspondent | Chris Kennelly EDWARDS LIFESCIENCES 1 EDWARDS WAY Irvine, CA 92614 |
| Product Code | OMZ |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-22 |
| Decision Date | 2016-01-07 |
| Summary: | summary |