# K193607: BOBBY Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jul 21, 2020 after 208 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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: 7 generations back to K010954 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153729: 8F FlowGate2 Balloon Guide Catheter, Concentric Medical (2016) Summary page 4.

## Most influential descendants
- K261549: BOBBY Balloon Guide Catheter (2026), 0 descendants of its own

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2912-2026: Due to an increase rate of balloon pinhole defects.

## Indications for use
The BOBBY Balloon Guide Catheter is intended: 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/K193607
Methodology: https://510kreport.com/methodology