# K153729: 8F FlowGate2 Balloon Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical
- Decided: Jan 27, 2016 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010954 (2001). 6 ancestors in all.
10 later devices descend from it; 7 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131492: Modified Flowgate Balloon Guide Catheter, Concentric Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K212340: EMBOGUARD Balloon Guide Catheter (2021), 1 descendant of its own
- K193607: BOBBY Balloon Guide Catheter (2020), 1 descendant of its own
- K200910: BOSS Balloon Guide Catheter (2020), 1 descendant of its own
- K261549: BOBBY Balloon Guide Catheter (2026), 0 descendants of its own
- K233924: EMBOGUARD Balloon Guide Catheter (2024), 0 descendants of its own

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1907-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc
- Apr 11, 2018 · Class II · Z-2569-2018: There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate an

## Indications for use
FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Source page: https://510kreport.com/device/K153729
Methodology: https://510kreport.com/methodology