# K022621: Boston Scientific Imager II 4F Selective Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Sep 4, 2002 after 28 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011664 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011664: Imager II Angiographic Catheter, Boston Scientific/Medi-Tech (2001)

## Most influential descendants
- K050863: Imager II Angiographic Catheter (2005), 1 descendant of its own
- K120893: Imager II Angiographic Catheters (2012), 0 descendants of its own

## Recalls of this device
- Mar 15, 2012 · Not classified · Z-1394-2012: Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found t

## Indications for use
The IMAGER™ II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.

Source page: https://510kreport.com/device/K022621
Methodology: https://510kreport.com/methodology