# K170616: van Andel Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 28, 2017 after 58 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924607 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123842: Lawmax Dilator, Lifetech Scientific (Shenzhen) Co., Ltd. (2013) Summary page 4.
- K153197: Fortress Introducer Sheath SYstem, Contract Medical International, GmbH (2016) Summary page 4.

## Indications for use
The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, catheters, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K170616
Methodology: https://510kreport.com/methodology