# K952828: Medi-Tech Percutaneous Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 18, 1995 after 59 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K170775: Mini Stick ENVI Non-Vascular Introducer Kit (2017), 0 descendants of its own

## Recalls of this device
- Jul 19, 2007 · Not classified · Z-0328-2008: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.

Source page: https://510kreport.com/device/K952828
Methodology: https://510kreport.com/methodology