CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
FDA 510(k) clearance K100663 · decided 2010-04-16
Clearance details
- K-number
- K100663
- Device name
- CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-03-08
- Decision date
- 2010-04-16
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- NAJ
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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