Unity Subcutaneous Infusion System for Remodulin
FDA 510(k) clearance K191313 · decided 2020-02-21
Clearance details
- K-number
- K191313
- Device name
- Unity Subcutaneous Infusion System for Remodulin
- Applicant
- DEKA Research & Development
- Decision
- Substantially Equivalent
- Date received
- 2019-05-15
- Decision date
- 2020-02-21
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- QJY
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Manchester, NH, 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.
| Record | Firm | Date |
|---|---|---|
| Remunity System (K243354) | Deka Research & Development Corp. | 2024-11-27 |
| Remunity System (K240256) | Deka Research and Development | 2024-06-12 |
| Remunity Pump for Remodulin (treprostinil) Injection (K202690) | Deka Research and Development | 2020-12-30 |
Recalls involving this device
No recalls on record reference this clearance.