DIACAP ULTRA DIALYSIS FLUID FILTER
FDA 510(k) clearance K052764 · decided 2006-06-09
Clearance details
- K-number
- K052764
- Device name
- DIACAP ULTRA DIALYSIS FLUID FILTER
- Applicant
- B. Braun Medizintechnologie GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-09-30
- Decision date
- 2006-06-09
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- FKQ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melsungen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria recall (Z-1183-2013) | B. Braun Medical, Inc. | 2013-04-26 |