# K965167: Percutaneous Venous Introducer 10264

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jul 25, 1997 after 213 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 K893658 (1989). 2 ancestors in all.
100 later devices descend from it; 2 cite it directly.
5 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893658: Percutaneous Introducer, Medamicus, Inc. (1989) Summary page 3.
- K951313: Medamicus Percutaneous Introducer, Medamicus, Inc. (1995) Summary page 3.

## Most influential descendants
- 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
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own

## Indications for use
The MedAmicus Percutaneous Introducer is indicated for use to access the venous side of the circulatory system to create an access port to conduct interventional procedures with catheters or implant long or short term interventional devices:

Source page: https://510kreport.com/device/K965167
Methodology: https://510kreport.com/methodology