# K893658: Percutaneous Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Aug 3, 1989 after 80 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.
101 later devices descend from it; 1 cites it directly.
5 of 102 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
- K965167: Percutaneous Venous Introducer 10264 (1997), 100 descendants of its own
- K012130: Attain LDS 6216 Left-Heart Delivery System (2001), 97 descendants of its own
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own

Source page: https://510kreport.com/device/K893658
Methodology: https://510kreport.com/methodology