CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
FDA 510(k) clearance K030966 · decided 2003-09-23
Clearance details
- K-number
- K030966
- Device name
- CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2003-03-27
- Decision date
- 2003-09-23
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- NAJ
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M recall (Z-2109-2009) | Boston Scientific Corporation | 2009-09-15 |
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