# K945229: Arrow Multipolar Intracardiac Electrode Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 8, 1995 after 286 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 30, 2018 · Class II · Z-3197-2018: Products are labeled with an incorrect expiration date

Source page: https://510kreport.com/device/K945229
Methodology: https://510kreport.com/methodology