# K202800: Pacific Plus PTA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)
- Decided: Nov 18, 2020 after 56 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: 5 generations back to K042537 (2004). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123358: Pacific Plus, Medtronic Vascular (2013) Summary page 4.

## Indications for use
The Pacific Plus PTA Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

Source page: https://510kreport.com/device/K202800
Methodology: https://510kreport.com/methodology