CELSITE PEDIATRIC VENOUS SYSTEM
FDA 510(k) clearance K952435 · decided 1996-04-17
Clearance details
- K-number
- K952435
- Device name
- CELSITE PEDIATRIC VENOUS SYSTEM
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-24
- Decision date
- 1996-04-17
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Melsungen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Numbe recall (Z-2528-2025) | B.Braun Medical S.A.S. | 2025-09-05 |