The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Conquest 40 Pta Dilatation Catheter, Atlas Gold Pta Dilatation Catheter, Vida Ptv Dilatation Catheter, Vida Bav Balloon Valvuloplasty Catheter.
| Device ID | K212588 |
| 510k Number | K212588 |
| Device Name: | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | C.R. Bard, Inc 1625 W Third Street Tempe, AZ 85281 |
| Contact | Arieona Boyle |
| Correspondent | Arieona Boyle C.R. Bard, Inc 1625 W Third Street Tempe, AZ 85281 |
| Product Code | DQY |
| Subsequent Product Code | LIT |
| Subsequent Product Code | OMZ |
| Subsequent Product Code | OZT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-05-04 |