# K031844: Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 15, 2003 after 29 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: 1 generation back to K030083 (2003). 1 ancestor in all.
6 later devices descend from it; 3 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)
- K030083: Vaxcel with Pasv Port, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K032375: Vaxcel Port, Models 45-336 and 45-338 (2003), 5 descendants of its own
- 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

## Recalls of this device
- Feb 25, 2005 · Not classified · Z-0782-05: Potential separation of the port base from the port cover after implantation.
- Feb 25, 2005 · Not classified · Z-0781-05: Potential separation of the port base from the port cover after implantation.
- Feb 10, 2004 · Not classified · Z-0733-04: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

## Indications for use
The VaxcelTM w/ PASVB 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/K031844
Methodology: https://510kreport.com/methodology