# K150452: ComboCath OTW PTA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Summa Therapeutics, LLC
- Decided: Aug 13, 2015 after 174 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 7 generations back to K001134 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111295: .014 Monorail and Otw Pta Balloon Dilatation Catheters, Boston Scientific Corporation (2011) Summary page 5.

## Most influential descendants
- K230263: Finesse™ Injectable PTA Balloon Dilatation Catheter (2023), 0 descendants of its own

## Indications for use
The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K150452
Methodology: https://510kreport.com/methodology