CAS-One Liver
FDA 510(k) clearance K143024 · decided 2015-04-28
Clearance details
- K-number
- K143024
- Device name
- CAS-One Liver
- Applicant
- Cascination AG
- Decision
- Substantially Equivalent
- Date received
- 2014-10-21
- Decision date
- 2015-04-28
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- OEW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bern, CH
- 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 |
|---|---|---|
| EXPLORER LIVER (PASSIVE TRACKING) (K101979) | Pathfinder Therapeutics, Inc. | 2011-02-09 |
| LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (K093494) | Pathfinder Therapeutics, Inc. | 2010-03-30 |
| LINASYS (K071063) | Pathfinder Therapeutics, Inc. | 2007-12-20 |
Recalls involving this device
No recalls on record reference this clearance.