# K021004: Valved Peelable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jun 6, 2002 after 70 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
Longest line of descent: 1 generation back to K932323 (1993). 2 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932323: Percutaneous Introducer, Medamicus, Inc. (1993) Summary page 1.
- K000824: Percutaneous Introducer, Model 10383-XXX, Medamicus, Inc. (2000) Summary page 2.

## Most influential descendants
- 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
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own

## Indications for use
The MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Source page: https://510kreport.com/device/K021004
Methodology: https://510kreport.com/methodology