# K230263: Finesse™ Injectable PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Summa Therapeutics, LLC
- Decided: May 26, 2023 after 115 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 8 generations back to K001134 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150452: ComboCath OTW PTA Dilatation Catheter, Summa Therapeutics, LLC (2015) Summary page 4.

## Recalls of this device
- Jul 21, 2025 · Class II · Z-1704-2026: Potential for the balloon in the device to not meet burst specifications.

## Indications for use
The Finesse Injectable™ PTA Balloon 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/K230263
Methodology: https://510kreport.com/methodology