GAMBRO FIBER PLASMAFILTER
FDA premarket approval P830063 · decided 1986-05-27
Approval details
- PMA number
- P830063
- Trade name
- GAMBRO FIBER PLASMAFILTER
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 1983-10-04
- Decision date
- 1986-05-27
- Days to decision
- 966 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Approval for the Gambro Fiber Plasmafilter PP. This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma components or protein bound toxins.
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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 |