# K143604: Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
- Decided: Jun 25, 2015 after 189 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 K943739 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943739: Softouch Diagnostic Intravascular Catheter, Mallinckrodt Medical (1994) Summary page 5.
- K000659: Modification to Softouch Diagnostic Intravascular Cat, Merit Medical Systems, Inc. (2000) Summary page 5.

## Indications for use
Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system. Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.

Source page: https://510kreport.com/device/K143604
Methodology: https://510kreport.com/methodology