# K032375: Vaxcel Port, Models 45-336 and 45-338

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 19, 2003 after 18 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030083 (2003). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031844: Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238, Boston Scientific Corp (2003)

## Most influential descendants
- K032600: Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233 (2003), 4 descendants of its own
- K122767: Nmi Port (2013), 3 descendants of its own
- K131694: Nmi Port II Catheter (2013), 2 descendants of its own
- K190559: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (2020), 0 descendants of its own
- K153228: NMI Port, NMI Port II (2015), 0 descendants of its own

## Recalls of this device
- Jun 8, 2005 · Not classified · Z-0944-05: Potential for port housing separation after implantation.
- Jun 8, 2005 · Not classified · Z-0945-05: Potential for port housing separation after implantation.
- Jun 8, 2005 · Not classified · Z-0946-05: Potential for port housing separation after implantation.

## Indications for use
The Vaxcel™ Port device is intended for use in-patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Source page: https://510kreport.com/device/K032375
Methodology: https://510kreport.com/methodology