PRISMAFLEX SYSTEM, VERSION 3.20
FDA 510(k) clearance K072093 · decided 2008-02-01
Clearance details
- K-number
- K072093
- Device name
- PRISMAFLEX SYSTEM, VERSION 3.20
- Applicant
- Gambro
- Decision
- Substantially Equivalent
- Date received
- 2007-07-30
- Decision date
- 2008-02-01
- Days to decision
- 186 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 System, Catalog Number 107493, Indicated for continuous solute and/or fluid rem recall (Z-1901-2011) | Gambro Renal Products, Incorporated | 2011-04-06 |