# K941706: Opti-Plast Angioplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vas-Cath, Inc.
- Decided: Oct 18, 1994 after 195 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033212: Lifestent SDS Biliary Endoprosthesis (2003), 2 descendants of its own
- K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis (2004), 1 descendant of its own
- K052132: Modification to: Lifestent Valeo Biliary Stent System (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K941706
Methodology: https://510kreport.com/methodology