# K892530: Catheters for Balloon Occlusion Femoral Angiograph

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Sep 26, 1989 after 168 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter (2007), 14 descendants of its own
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) (2012), 4 descendants of its own
- K190855: BD Acute Central Line (2019), 3 descendants of its own
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), 3 descendants of its own
- K091709: Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC (2009), 2 descendants of its own

## Recalls of this device
- Nov 15, 2019 · Class II · Z-0715-2020: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placemen
- Nov 15, 2019 · Class II · Z-0716-2020: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placemen
- Mar 4, 2013 · Class II · Z-1057-2013: The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer a

Source page: https://510kreport.com/device/K892530
Methodology: https://510kreport.com/methodology