# K042538: Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Invatec Innovative Technologies
- Decided: Nov 8, 2004 after 49 days
- Product code: DQY (Catheter, Percutaneous)
- 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
No predicates in its family tree.
57 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis OPTA PRO Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K062809: Admiral Xtreme Pta Catheter (2006), 53 descendants of its own
- K082579: Evercross .035 Otw Pta Dilatation Catheter (2008), 35 descendants of its own
- K093286: Powercross .018 Otw Pta Dilation Catheter (2009), 14 descendants of its own
- K100921: Admiral Xtreme Pta Balloon Dilatation Catheter (2010), 12 descendants of its own
- K103464: Pacific Xtreme Ptca Balloon Dilatation Catheter (2010), 9 descendants of its own

## Indications for use
The SAILOR TM PLUS PTA Balloon Dilatation Catheter is intended to dilate stenoses in 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/K042538
Methodology: https://510kreport.com/methodology