THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
FDA 510(k) clearance K100819 · decided 2010-08-02
Clearance details
- K-number
- K100819
- Device name
- THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- Applicant
- Onset Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-03-23
- Decision date
- 2010-08-02
- Days to decision
- 132 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI- recall (Z-1374-2019) | Terumo Medical Corporation | 2019-05-28 |