# K081147: Isoflow Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Designs, Inc.
- Decided: May 29, 2009 after 402 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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 K913517 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter, Scimed Life Systems, Inc. (1993) Summary page 1.
- K913517: Isolate Infusion Cathetr System, Lake Region Mfg., Inc. (1991) Summary page 1.

## Most influential descendants
- K130569: ND Nabil Dib Infusion Catheter (2013), 0 descendants of its own

## Indications for use
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

Source page: https://510kreport.com/device/K081147
Methodology: https://510kreport.com/methodology