CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
FDA 510(k) clearance K130576 · decided 2013-04-02
Clearance details
- K-number
- K130576
- Device name
- CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
- Applicant
- B. Braun Interventional Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-05
- Decision date
- 2013-04-02
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Minneapolis, MN, US
- 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 |
| Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port S recall (Z-2382-2015) | B. Braun Interventional Systems | 2015-08-13 |