# K982141: Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 31, 1998 after 75 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892410 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 1.
- (no number) Arrow 5 Fr Balloon Wedge Pressure Catheter: named in the summary without a submission number

## Indications for use
The Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.

Source page: https://510kreport.com/device/K982141
Methodology: https://510kreport.com/methodology