# K123358: Pacific Plus

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jan 29, 2013 after 90 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: 4 generations back to K042537 (2004). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103464: Pacific Xtreme Ptca Balloon Dilatation Catheter, Medtronic, Inc. (2010) Summary page 2.
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 2.
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2009) Summary page 2.
- K092361: Reef HP 0.035 Otw Pta Balloon Dilatation Catheter, Invatec S.P.A. (2009) Summary page 2.

## Most influential descendants
- K202800: Pacific Plus PTA Catheter (2020), 0 descendants of its own

## Indications for use
The PacificTM 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.

Source page: https://510kreport.com/device/K123358
Methodology: https://510kreport.com/methodology