# K960200: Introstat Lead Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Msi, Inc.
- Decided: Jul 2, 1996 after 181 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 4, 2003 · Not classified · Z-0255-04: The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
- Nov 4, 2003 · Not classified · Z-0254-04: The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
- Nov 4, 2003 · Not classified · Z-0257-04: The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
- Nov 4, 2003 · Not classified · Z-0256-04: The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

Source page: https://510kreport.com/device/K960200
Methodology: https://510kreport.com/methodology