CELSITE/ CELSITE CONCEPT, ACCESS PORTS
FDA 510(k) clearance K061424 · decided 2006-07-31
Clearance details
- K-number
- K061424
- Device name
- CELSITE/ CELSITE CONCEPT, ACCESS PORTS
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-23
- Decision date
- 2006-07-31
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, S recall (Z-2671-2011) | B. Braun Interventional Systems | 2011-06-27 |
| Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the recall (Z-1961-2009) | B. Braun Interventional Systems | 2009-09-03 |