# K001578: Angiodynamics Soft-VU Hydrophilic Coated Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Oct 13, 2000 after 144 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K053171: Merit Impress Diagnostic Catheter (2006), 10 descendants of its own
- K093004: Impress Angiographic Catheter with Hydrophilic Coating (2010), 4 descendants of its own
- K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits (2012), 3 descendants of its own
- K191608: Impress Angiographic Catheter (2019), 2 descendants of its own
- K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer (2015), 1 descendant of its own

## Recalls of this device
- Jun 1, 2016 · Class I · Z-2096-2016: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Source page: https://510kreport.com/device/K001578
Methodology: https://510kreport.com/methodology