V8 Balloon Aortic Valvuloplasty Catheter
InterValve, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010133561 | 3010133561 | InterValve Medical, Inc. | 1 | N | 2020-04-25 | 6 Morgan Suite 130 Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859945004068 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, 172212C110 | 6123969849 | spetrie@libramed.com |
| 00859945004075 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, 192412C110 | 6123969849 | spetrie@libramed.com |
| 00859945004082 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, 212612C110 | 6123969849 | spetrie@libramed.com |
| 00859945004099 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, 232812C110 | 6123969849 | spetrie@libramed.com |
| 00859945004105 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, V8-1722 | 6123969849 | spetrie@libramed.com |
| 00859945004112 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, V8-1924 | 6123969849 | spetrie@libramed.com |
| 00859945004129 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, V8-2126 | 6123969849 | spetrie@libramed.com |
| 00859945004136 | V8 - V8 Balloon Aortic Valvuloplasty Catheter, V8-2328 | 6123969849 | spetrie@libramed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 209214 | 1538644355 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter | OZT | 2015-12-18 |
| 209214 | 1238201700 | K150343 | V8 Transluminal BAV Catheter | OZT | 2015-04-03 |
| 209214 | 1881522791 | K133607 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2014-02-11 |
| 209214 | 1135155565 | K132728 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2013-11-22 |
| 209214 | 1667805471 | K123111 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2013-01-31 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OZT | 5 | 2015-12-18 |
InterValve, Inc.
InterValve, Inc.
INTERVALVE, INC
INTERVALVE, INC
INTERVALVE, INC
2016-09-08
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