Loma Vista Medical
FDA Regulatory Profile
Loma Vista Medical appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1566-2013, Class II) was initiated on March 18, 2013. Its most recent 510(k) clearance was granted on October 11, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1566-2013 | Class II | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 0 | March 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERC | October 11, 2012 |