# K130576: Celsite Implantable Access Port Systems

- Pathway: 510(k) (Special)
- Applicant: B. Braun Interventional Systems, Inc.
- Decided: Apr 2, 2013 after 28 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952548 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061424: Celsite/ Celsite Concept, Access Ports, Aesculap, Inc. (2006) Summary page 1.
- K993024: Celsite Implantable Port with Valved Catheter, B. Braun of America, Inc. (2000) Summary page 1.
- K994111: Celsite, Models ST401L, ST405L, B. Braun/Mcgaw (2000) Summary page 1.
- K962230: Celsite Port with Preconnected Catheter, B.Braun Medical, Inc. (1996) Summary page 1.
- K952548: Celsite Venous System, B.Braun Medical, Inc. (1995) Summary page 1.
- K952435: Celsite Pediatric Venous System, B.Braun Medical, Inc. (1996) Summary page 1.
- K945752: Celsite (TM) Brachial Venous Port, B. Braun of America, Inc. (1995) Summary page 1.
- K945551: Celsite (TM) Dual Venous System, B. Braun of America, Inc. (1995) Summary page 1.

## Recalls of this device
- Jul 21, 2025 · Class II · Z-2528-2025: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
- Jun 16, 2015 · Class II · Z-2382-2015: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

## Indications for use
Celsite Access Ports are indicated for patient therapies requiring repeated access to the vascular system. Celsite / Celsite Concept Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions. Celsite Discreet / Celsite Dual Venous / Celsite Brachial / Celsite Babyport / Celsite Babyport S Ports are recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

Source page: https://510kreport.com/device/K130576
Methodology: https://510kreport.com/methodology