PRISMAFLEX M150 SET
FDA 510(k) clearance K080519 · decided 2008-06-13
Clearance details
- K-number
- K080519
- Device name
- PRISMAFLEX M150 SET
- Applicant
- Gambro Renal Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-25
- Decision date
- 2008-06-13
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Seal recall (Z-1228-2026) | VANTIVE US HEALTHCARE LLC | 2026-02-02 |
| Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid manage recall (Z-0082-2023) | Baxter Healthcare Corporation | 2022-10-12 |
| Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2203-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |