Company ยท US
Intervalve, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2015. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2015 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter Intervalve, Inc. | OZT |
| Apr 3, 2015 | K150343 | V8 Transluminal BAV Catheter Intervalve, Inc. | OZT |
| Feb 11, 2014 | K133607 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
| Nov 22, 2013 | K132728 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
| Jan 31, 2013 | K123111 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2014 | InterValve Inc InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. Terminated |
OZT | K133607 |