Contour Se Microspheres
by Boston Scientific 2 variants
510(k) K034068
Contour Se Microspheres is a Class II device made by Boston Scientific, cleared under FDA 510(k) K034068 on 26 Mar 2004, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK034068 | Date26 Mar 2004 | StatusActive |
Official records
- FDA 510(k) database K034068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KRD
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 870.3300
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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