# K061424: Celsite/ Celsite Concept, Access Ports

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 31, 2006 after 69 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: 2 generations back to K952548 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 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.
- K952548: Celsite Venous System, B.Braun Medical, Inc. (1995) Summary page 1.
- K954297: Celsite Venous Access System Otw, B.Braun Medical, Inc. (1995) Summary page 1.
- K962230: Celsite Port with Preconnected Catheter, B.Braun Medical, Inc. (1996) Summary page 1.
- K993024: Celsite Implantable Port with Valved Catheter, B. Braun of America, Inc. (2000) Summary page 1.
- K032557: Triumph VTX with Lifevalve Catheter, Horizon Medical Products, Inc. (2003) Summary page 1.
- K992697: Port-a-Cath II Trans-Arterial Percutaneous System, Sims Deltec, Inc. (1999) Summary page 1.
- K932840: Port-a-Cath Implantable Vascular Access System, Pharmacia Deltec, Inc. (1994) Summary page 1.

## Most influential descendants
- 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.

## Indications for use
The Aesculap 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.

Source page: https://510kreport.com/device/K061424
Methodology: https://510kreport.com/methodology