Intervalve, Inc.
Minneapolis, MN, US
Intervalve, Inc. appears in FDA device records in Minneapolis, MN. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Intervalve, Inc. between 2013 and 2015. The busiest year on record is 2013, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | OZT | Substantially Equivalent | |
| K150343 | V8 Transluminal BAV Catheter | OZT | Substantially Equivalent | |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | OZT | Substantially Equivalent | |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | OZT | Substantially Equivalent | |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | OZT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1621-2014 | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. | Leak issues were discovered through accelerated age testing. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain