InterValve Inc
FDA Regulatory Profile
InterValve Inc appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1621-2014, Class II) was initiated on March 14, 2014. Its most recent 510(k) clearance was granted on December 18, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1621-2014 | Class II | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 2328 | March 14, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | December 18, 2015 |
| K150343 | V8 Transluminal BAV Catheter | April 3, 2015 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | February 11, 2014 |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | November 22, 2013 |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | January 31, 2013 |