# K991431: 14 FR. Hemodialysis Two-Lumen Catheterization Kit

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: May 26, 1999 after 30 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) ARROW 12 Fr Large-Bore Dual Lumen Hemodialysis Catheterization Kit: named in the summary without a submission number

## Recalls of this device
- Feb 18, 2004 · Not classified · Z-0639-04: catheter slips out of the suture wing during use.

## Indications for use
The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.

Source page: https://510kreport.com/device/K991431
Methodology: https://510kreport.com/methodology