# K000824: Percutaneous Introducer, Model 10383-XXX

- Pathway: 510(k) (Special)
- Applicant: Medamicus, Inc.
- Decided: Apr 13, 2000 after 30 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 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
- K021004: Valved Peelable Introducer (2002), 21 descendants of its own
- K030905: Medamicus Flowguard Peelable Introducer (2003), 20 descendants of its own
- K040150: Modification to Medamicus Flowguard Peelable Introducer (2004), 19 descendants of its own
- K090394: Valved Tearway Introducer (2009), 12 descendants of its own
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own

Source page: https://510kreport.com/device/K000824
Methodology: https://510kreport.com/methodology