Optima Coil System (OptiBlock Line Extension)
FDA 510(k) clearance K242582 · decided 2024-09-27
Clearance details
- K-number
- K242582
- Device name
- Optima Coil System (OptiBlock Line Extension)
- Applicant
- Balt USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-08-30
- Decision date
- 2024-09-27
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.