# K121694: Imager II Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 14, 2012 after 99 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 4 (2 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). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 5 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.
- K023681: Renegade STC 18 Microcatheter, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter (2015), 1 descendant of its own
- K161822: Torcon NB Advantage Catheters (2016), 0 descendants of its own

## Recalls of this device
- Aug 24, 2026 · Class I · Z-3214-2026: Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
- Feb 11, 2020 · Class I · Z-1555-2020: Potential for tip detachment of Imager II 5F Angiographic Catheters
- Dec 15, 2016 · Class II · Z-2645-2017: A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
- Dec 13, 2016 · Class II · Z-1781-2017: One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra c

## Indications for use
The Imager 11Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries. Additionally, the 5F Seleactive Imager 11Arigiographic Catheters without sideholes can be used for the controlled and selective delivery of the Boston Scientific lnterlockTh-35 Detachable Coils into the peripheral vasculature.

Source page: https://510kreport.com/device/K121694
Methodology: https://510kreport.com/methodology