# K112452: Angiodynamics Soft-VU Angiographic Catheters

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Mar 30, 2012 after 218 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151724: AngioDynamics Mariner Angiographic Catheters (2015), 2 descendants of its own
- K161596: Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters (2017), 1 descendant of its own
- K173762: AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters (2018), 0 descendants of its own
- K122506: Surefire High Flow Angiographic Catheter, Access (2012), 0 descendants of its own

## Recalls of this device
- Mar 3, 2026 · Class II · Z-1861-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1874-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1859-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1872-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1866-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1864-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1868-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1875-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1863-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1867-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1858-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1856-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1871-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1860-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1862-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1869-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1870-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1873-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Mar 3, 2026 · Class II · Z-1865-2026: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Sep 22, 2017 · Class II · Z-0742-2018: Product was placed into distribution prior to completion of all required post sterilization release activities.

## Indications for use
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Source page: https://510kreport.com/device/K112452
Methodology: https://510kreport.com/methodology