BRAUN HEMODIALYSIS BLOOD CIRCUITS
FDA 510(k) clearance K952631 · decided 1996-04-30
Clearance details
- K-number
- K952631
- Device name
- BRAUN HEMODIALYSIS BLOOD CIRCUITS
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-08
- Decision date
- 1996-04-30
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. Th recall (Z-1035-2008) | B. Braun Medical, Inc. | 2008-05-07 |
| Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. Th recall (Z-1036-2008) | B. Braun Medical, Inc. | 2008-05-07 |