# K221245: PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kossel Medtech (Suzhou) Co., Ltd.
- Decided: Dec 14, 2022 after 226 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: 9 generations back to K001134 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter, Cordis Corporation (2014) Summary page 4.

## Indications for use
The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, ilio-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/K221245
Methodology: https://510kreport.com/methodology