# K032008: Vaxcel with Pasv Port, Model 45-213

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 14, 2003 after 14 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Vaxcel™ Implantable port system: named in the summary without a submission number
- (no number) PASVB implantable port system: named in the summary without a submission number
- (no number) Vaxcel™ with PASVB PICC: named in the summary without a submission number

## 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
- May 13, 2010 · Not classified · Z-1876-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1880-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1879-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1878-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1874-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1877-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1875-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- Jul 22, 2005 · Not classified · Z-1472-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

## Indications for use
The Vaxcel'M 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/K032008
Methodology: https://510kreport.com/methodology