Prismaflex TPE2000 Set
FDA premarket approval P830063/S013 · decided 2021-02-12
Approval details
- PMA number
- P830063
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prismaflex TPE2000 Set
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2019-09-23
- Decision date
- 2021-02-12
- Days to decision
- 508 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Approval for a change in the parting line on the blood ports of the support plate of the manufacturing mold.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |