PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
FDA 510(k) clearance K011221 · decided 2001-10-31
Clearance details
- K-number
- K011221
- Device name
- PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2001-04-20
- Decision date
- 2001-10-31
- Days to decision
- 194 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 |
|---|---|---|
| Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plasti recall (Z-2200-2014) | Gambro Renal Products, Incorporated | 2014-08-13 |
| Gambro Prisma HF1000 preset, Part No. 8399050. recall (Z-0706-06) | Gambro Renal Products, Inc. | 2006-04-05 |