# K050863: Imager II Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 2, 2005 after 150 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011664 (2001). 2 ancestors in all.
1 later device descends 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) Summary page 1.
- K022621: Boston Scientific Imager II 4F Selective Angiographic Catheter, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- 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
- Oct 22, 2009 · Not classified · Z-0336-2010: The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agen
- Oct 12, 2007 · Not classified · Z-0279-2008: Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

## 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 including the carotid arteries

Source page: https://510kreport.com/device/K050863
Methodology: https://510kreport.com/methodology