# K061733: Angiodynamics Soft-VU and Mariner Hydrophilic Coated Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Aug 24, 2006 after 65 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K073200: Gandras Intravascular Catheter, Models 5580, 5581 and 5582 (2008), 0 descendants of its own

## Recalls of this device
- Jun 15, 2012 · Class II · Z-2180-2012: AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
- Jun 7, 2011 · Not classified · Z-3259-2011: The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.

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

Source page: https://510kreport.com/device/K061733
Methodology: https://510kreport.com/methodology