AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
FDA 510(k) clearance K141019 · decided 2014-06-10
Clearance details
- K-number
- K141019
- Device name
- AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
- Applicant
- Fenwal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-21
- Decision date
- 2014-06-10
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lake Zurich, IL, US
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PLASMA SEPARATION SYSTEM (P820032/S005) | Fenwal, Inc. | 1987-08-25 |
| PLASMA SEPARATION SYSTEM (P820032/S004) | Fenwal, Inc. | 1985-07-09 |
| PLASMA SEPARATION SYSTEM (P820032/S002) | Fenwal, Inc. | 1984-06-13 |
| PLASMA SEPARATION SYSTEM (P820032/S003) | Fenwal, Inc. | 1984-06-13 |
| PLASMA SEPARATION SYSTEM (P820032/S001) | Fenwal, Inc. | 1983-12-05 |
| PLASMA SEPARATION SYSTEM (P820032) | Fenwal, Inc. | 1983-10-07 |