# K952548: Celsite Venous System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 21, 1995 after 49 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993024: Celsite Implantable Port with Valved Catheter (2000), 2 descendants of its own
- K962230: Celsite Port with Preconnected Catheter (1996), 2 descendants of its own
- 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
- Jun 22, 2009 · Not classified · Z-1961-2009: B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections.

Source page: https://510kreport.com/device/K952548
Methodology: https://510kreport.com/methodology