Sapphire Infusion Pump, Sapphire administration sets
FDA 510(k) clearance K192860 · decided 2020-11-19
Clearance details
- K-number
- K192860
- Device name
- Sapphire Infusion Pump, Sapphire administration sets
- Applicant
- Q Core Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-04
- Decision date
- 2020-11-19
- Days to decision
- 412 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-0 recall (Z-0094-2024) | EITAN MEDICAL LTD | 2023-10-20 |