# K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Flowmedica, Inc.
- Decided: Jan 13, 2004 after 62 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904788 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904788: Mewissen Catheter, Boston Scientific Corp (1990) Summary page 2.
- K955525: Flower Infusion Catheter Model F-25/50, F-60/70, Interventional Innovations Corp. (1996) Summary page 2.
- K030637: Ekos Peripheral Infusion System, Ekos Corp. (2003) Summary page 2.
- K883880: Katzen Thrombolysis Guidewire, Medi-Tech, Inc. (1989) Summary page 2.
- K897152: Cragg Convertible Wire, Boston Scientific Corp (1990) Summary page 2.
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 2.
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 2.
- K012854: Renal Guiding Sheath, Terumo Medical Corp. (2001)
- (no number) Cook Check-Flo Performer Introducer: named in the summary without a submission number
- (no number) Cook Shuttle SL Flexor Tuohy-Borst Side Arm Introducer Set: named in the summary without a submission number

## Most influential descendants
- K082163: Flowmedica Benephit Infusion Systems (2008), 0 descendants of its own

## Recalls of this device
- Apr 30, 2010 · Not classified · Z-1734-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod
- Apr 30, 2010 · Not classified · Z-1733-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod

## Indications for use
Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Source page: https://510kreport.com/device/K033569
Methodology: https://510kreport.com/methodology