# K952435: Celsite Pediatric Venous System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 17, 1996 after 329 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 K902401 (1991). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902401: Celsite (TM) Implantable Drug Delivery System, Burron Medical, Inc. (1991) Summary page 1.
- K942024: Port-a-Cath Low Profile Implantable Venous Access System, Pharmacia Deltec, Inc. (1994) Summary page 1.

## Most influential descendants
- K110424: Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil (2011), 1 descendant of its own
- K130576: Celsite Implantable Access Port Systems (2013), 0 descendants of its own
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K952435
Methodology: https://510kreport.com/methodology