# K120893: Imager II Angiographic Catheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 29, 2012 after 6 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: 3 generations back to K011664 (2001). 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)
- K050863: Imager II Angiographic Catheter, Boston Scientific Corp (2005) Summary page 1.

## Indications for use
The Imager 11 Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

Source page: https://510kreport.com/device/K120893
Methodology: https://510kreport.com/methodology