The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for True Dilatation Balloon Valvuloplasty Catheter, 20mm X 4.5 Cm, 22mm X 4.5cm, 24 Mm X 4.5cm, 26mm X 4.5cm.
| Device ID | K133569 |
| 510k Number | K133569 |
| Device Name: | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1307 SOUTH MARY AVENUE SUITE 280 Sunnyvale, CA 94087 |
| Contact | Tiffini Diage |
| Correspondent | Tiffini Diage BARD PERIPHERAL VASCULAR, INC. 1307 SOUTH MARY AVENUE SUITE 280 Sunnyvale, CA 94087 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-20 |
| Decision Date | 2013-12-20 |
| Summary: | summary |