# K161336: VSI StraitSet micro-introducer kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 11, 2016 after 90 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: 2 generations back to K000737 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071330: Galtstick Introducer System, Galt Medical Corp. (2007) Summary page 4.

## Indications for use
The VSI StraitSet micro-introducer kit is intended for use in percutaneous introduction and placement of catheters and guidewires.

Source page: https://510kreport.com/device/K161336
Methodology: https://510kreport.com/methodology