# K182399: Park Blade Septostomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 4, 2019 after 212 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801031 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801031: Blade Septostomy Catheter, Cook, Inc. (1980) Summary page 4.

## Indications for use
The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.

Source page: https://510kreport.com/device/K182399
Methodology: https://510kreport.com/methodology