COAPTIUM Connect with TISSIUM LIGHT
FDA 510(k) clearance DEN240066 · decided 2025-06-17
Clearance details
- K-number
- DEN240066
- Device name
- COAPTIUM Connect with TISSIUM LIGHT
- Applicant
- Tissium SA
- Decision
- Unknown
- Date received
- 2024-11-21
- Decision date
- 2025-06-17
- Days to decision
- 208 days
- Clearance type
- Direct
- Product code
- SFD
- Device class
- 2
- Regulation number
- 882.5270
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Coaptium Connect with Tissium Light (K251957) | Tissium SA | 2025-09-08 |
Recalls involving this device
No recalls on record reference this clearance.