# K971619: Microfuse Membrane Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: E-Med Corp.
- Decided: Feb 27, 1998 after 302 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 K932616 (1993). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 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.
- K931027: Bullett Peripheral Infusion Catheter, Cardio-Dynamics, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K933549: Vidas CMV Igm Assay, Biomerieux Vitek, Inc. (1994). Our OCR of the scanned summary read K933549, FDA’s number for Vidas CMV Igm Assay (Biomerieux Vitek, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (2006), 9 descendants of its own
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own

## Indications for use
E-Med’s Microfuse Membrane Infusion Catheter is a nondilatation over-the-wire device intended for the localized infusion of therapeutic solution(s) in the coronary vasculature through a microporous membrane. The catheter is intended to be coaxially tracked over a guidewire to access a subselective infusion region in the coronary vasculature. The technique, rate of administration, duration of infusion, and appropriate sizing of the membrane to the arterial diameter is determined by the operating physician. The infusion solution should be used in accordance with the manufacturer’s instructions for use.

Source page: https://510kreport.com/device/K971619
Methodology: https://510kreport.com/methodology