# K143613: PaxWire Occlusion Balloon System

- Pathway: 510(k) (Traditional)
- Applicant: Accessclosure, Inc.
- Decided: Aug 14, 2015 after 238 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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: 2 generations back to K062202 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132990: Occlusion Balloon Catheter, Boston Scientific Corp (2013) Summary page 5.
- K930622: Amplatz Guidewires, Meadox Medicals, Div. Boston Scientific Corp. (1993) Summary page 5.

## Recalls of this device
- Oct 6, 2016 · Class II · Z-0297-2017: AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath

## Indications for use
The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery.

Source page: https://510kreport.com/device/K143613
Methodology: https://510kreport.com/methodology