# K993024: Celsite Implantable Port with Valved Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun of America, Inc.
- Decided: Mar 13, 2000 after 186 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952548 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952548: Celsite Venous System, B.Braun Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K061424: Celsite/ Celsite Concept, Access Ports (2006), 1 descendant of its own
- K130576: Celsite Implantable Access Port Systems (2013), 0 descendants of its own

## Recalls of this device
- Apr 13, 2011 · Not classified · Z-2671-2011: The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications an

## Indications for use
Used intravenously over a long period of time for the administration of drugs for chemotherapy (antibiotics); also used for blood transfusions or blood sampling in small quantities.

Source page: https://510kreport.com/device/K993024
Methodology: https://510kreport.com/methodology