VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
FDA 510(k) clearance K072798 · decided 2008-01-31
Clearance details
- K-number
- K072798
- Device name
- VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
- Applicant
- Abbott Vascular-Vascular Solutions
- Decision
- Substantially Equivalent
- Date received
- 2007-10-01
- Decision date
- 2008-01-31
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-1 recall (Z-1178-2010) | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 2010-03-22 |