MODIFICATION TO:CONTOUR SE MICROSPHERES
FDA 510(k) clearance K071634 · decided 2007-07-12
Clearance details
- K-number
- K071634
- Device name
- MODIFICATION TO:CONTOUR SE MICROSPHERES
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2007-06-15
- Decision date
- 2007-07-12
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.