The following data is part of a premarket notification filed by Intervalve, Inc. with the FDA for V8 Transluminal Bav Catheter.
| Device ID | K150343 |
| 510k Number | K150343 |
| Device Name: | V8 Transluminal BAV Catheter |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | InterValve, Inc. 2445 Xenium Lane Plymouth, MN 55441 |
| Contact | Mark Ungs |
| Correspondent | Ming Cheng Chew Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, 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 | 2015-02-11 |
| Decision Date | 2015-04-03 |
| Summary: | summary |