# K203840: BOSS 8F Balloon Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Marblehead Medical, LLC
- Decided: Jan 28, 2021 after 28 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010954 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200910: BOSS Balloon Guide Catheter, Marblehead Medical (2020) Summary page 4.

## Indications for use
The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K203840
Methodology: https://510kreport.com/methodology