# K960479: Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 17, 1996 after 258 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832850 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832850: Elecath Pacewedge Dual Press. Bipolar, Electro-Catheter Corp. (1983) Summary page 1.
- K844003: Elecath Ventricular Pacing Wedge Pressure Cath, Electro-Catheter Corp. (1984) Summary page 1.
- (no number) Balloon Temporary Bipolar Pacing Catheter: named in the summary without a submission number
- (no number) Balloon Wedge Pressure catheter: named in the summary without a submission number

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2383-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Feb 11, 2009 · Not classified · Z-1500-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Apr 1, 2008 · Not classified · Z-1908-2008: The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
- Apr 1, 2008 · Not classified · Z-1907-2008: The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.

## Indications for use
The ARROW catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). The second pressure lumen allows infusion of a solution with simultaneous measurement of pressure. The catheter is intended for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording only.

Source page: https://510kreport.com/device/K960479
Methodology: https://510kreport.com/methodology