# K011664: Imager II Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific/Medi-Tech
- Decided: Sep 7, 2001 after 100 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NightHawk Angiographic Catheter: named in the summary without a submission number

## Most influential descendants
- K121694: Imager II Angiographic Catheter (2012), 2 descendants of its own
- K022621: Boston Scientific Imager II 4F Selective Angiographic Catheter (2002), 2 descendants of its own
- K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter (2015), 1 descendant of its own
- K050863: Imager II Angiographic Catheter (2005), 1 descendant of its own
- K161822: Torcon NB Advantage Catheters (2016), 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 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 indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.

Source page: https://510kreport.com/device/K011664
Methodology: https://510kreport.com/methodology