The following data is part of a premarket notification filed by Intervalve, Inc with the FDA for V8 Transluminal Bav Catheter.
| Device ID | K132728 |
| 510k Number | K132728 |
| Device Name: | V8 TRANSLUMINAL BAV CATHETER |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | INTERVALVE, INC 84801 73RD AVENUE NORTH, SUITE 63 Minneapolis, MN 55428 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay INTERVALVE, INC 84801 73RD AVENUE NORTH, SUITE 63 Minneapolis, MN 55428 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-11-22 |
| Summary: | summary |