# K897106: Medi-Tech Dilatation Catheters Ultra Thin II

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 16, 1990 after 299 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K961980: Bipore Balloon Dilatation Catheter (1996), 2 descendants of its own
- K041293: Biopore Balloon Dilation Catheter (2004), 0 descendants of its own
- K973563: Bipore Balloon Dilatation Catheter (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K897106
Methodology: https://510kreport.com/methodology