510(k) · Cleared
Recalled · Class I · 2026Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Oct 17, 1996 as substantially equivalent to K832850 (Electro-Catheter Corp., 1983) and 1 other predicate after a 258-day review. Its family tree reaches back 1 generation to 1983. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Oct 17, 1996
- Review
- 258 days
- Class
- Class II
- Product code
- LDF
- Recalls
- 4 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832850 (1983). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK832850 Elecath Pacewedge Dual Press. BipolarElectro-Catheter Corp. · 1983
- This deviceK960479 Arrow Bipolar Pacing/Balloon Wedge Pressure CatheterArrow Intl., Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832850 | Elecath Pacewedge Dual Press. Bipolar | Electro-Catheter Corp. | 1983 | — |
| 0 (this device) | K960479 | Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter | Arrow Intl., Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDF device
- #1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K832850 | Elecath Pacewedge Dual Press. BipolarSummary page 1…ecath® Ventricular Pacewedge® Pacing and Pressure Catheter, open tip, 996 catalog no. 34-6567, from the Electro-Catheter Corporation, Rahway, NJ, Premarket Notifications K832850 and K844003. 2. A combination of two Arrow pre-enactment catheters, the Balloon Temporary Bipolar Pacing Catheter and the Balloo… | 1983 |
| * | K844003 | Elecath Ventricular Pacing Wedge Pressure CathSummary page 1…icular Pacewedge® Pacing and Pressure Catheter, open tip, 996 catalog no. 34-6567, from the Electro-Catheter Corporation, Rahway, NJ, Premarket Notifications K832850 and K844003. 2. A combination of two Arrow pre-enactment catheters, the Balloon Temporary Bipolar Pacing Catheter and the Balloon Wedge Pres… | 1984 |
| * | — | Balloon Temporary Bipolar Pacing Catheter Named without a submission number | |
| * | — | Balloon Wedge Pressure catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2383-2026 | Nonconforming Material/Component | 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 ineffectiveness, and if sterility of a… |
| Feb 11, 2009 | Not classified | Z-1500-2009 | Device Design | 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 | Process control | 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 | Process control | The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 2025
MAUDE reports naming product code LDF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 25 |
| 2008 | 1 | — | 2 | 18 |
| 2009 | 0 | — | 2 | 44 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 1 | 35 |
| 2012 | 0 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 1 | — | 0 | 68 |
| 2015 | 2 | — | 0 | 81 |
| 2016 | 3 | 138 | 0 | 90 |
| 2017 | 1 | — | 0 | 79 |
| 2018 | 1 | — | 1 (1) | 91 |
| 2019 | 1 | — | 0 | 130 |
| 2020 | 0 | — | 0 | 83 |
| 2021 | 0 | — | 0 | 125 |
| 2022 | 0 | — | 0 | 117 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 1 | — | 0 | 190 |
| 2025 | 5 | 266 | 0 | 139 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960479: Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960479
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026