# K201246: PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

- Pathway: 510(k) (Traditional)
- Applicant: Qualimed USA, LLC
- Decided: Aug 3, 2021 after 452 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: 1 generation back to K971010 (1997). 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)
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 6.

## Indications for use
The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including 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/K201246
Methodology: https://510kreport.com/methodology