TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
FDA 510(k) clearance K121083 · decided 2012-10-11
Clearance details
- K-number
- K121083
- Device name
- TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
- Applicant
- Loma Vista Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-04-10
- Decision date
- 2012-10-11
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, recall (Z-1566-2013) | Loma Vista Medical | 2013-06-21 |