# K073200: Gandras Intravascular Catheter, Models 5580, 5581 and 5582

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 1, 2008 after 80 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020012 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023681: Renegade STC 18 Microcatheter, Boston Scientific Corp (2002) Summary page 1.
- K020012: Modification to Renegade Fiber Braided Microcatheter, Boston Scientific/Medi-Tech (2002) Summary page 1.
- K061733: Angiodynamics Soft-VU and Mariner Hydrophilic Coated Angiographic Catheter, AngioDynamics, Inc. (2006) Summary page 1.

## Indications for use
The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

Source page: https://510kreport.com/device/K073200
Methodology: https://510kreport.com/methodology