The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for True Dilatation Balloon Valvuloplasty Catheter.
| Device ID | K150667 |
| 510k Number | K150667 |
| Device Name: | True Dilatation Balloon Valvuloplasty Catheter |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | C.R. Bard, Inc. 1625 W. Third St. Tempe, AZ 85281 |
| Contact | Aaron Conovaloff |
| Correspondent | Aaron Conovaloff C.R. Bard, Inc. 1625 W. Third St. Tempe, AZ 85281 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-06-17 |
| Summary: | summary |