# K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 5, 2007 after 122 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810412 (1981). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000659: Modification to Softouch Diagnostic Intravascular Cat, Merit Medical Systems, Inc. (2000) Summary page 1.
- K000737: Coaxial Dilator Set, Xentek Medical, Inc. (2000) Summary page 1.
- K061565: Langston Dual Lumen Catheter, Vascular Solutions, Inc. (2006) Summary page 1.

## Most influential descendants
- K073585: Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905 (2008), 1 descendant of its own
- K081846: Grebset Micro-Introducer Kit, Models 7950, 7951 (2009), 0 descendants of its own

## Indications for use
The InnerChange TM micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Source page: https://510kreport.com/device/K062627
Methodology: https://510kreport.com/methodology