Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath

FDA 510(k) K050205 · Flowmedica, Inc.

Substantially Equivalent

510(k) numberK050205

Submission

Device name
Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath
Applicant
Flowmedica, Inc.
Fremont, CA, US
Received
January 28, 2005
Decision date
March 4, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KRA – Catheter, Continuous Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1210
Specialty
Cardiovascular

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K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional Transit Scientific, LLC11/29/2023SE
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional Ablative Solutions, Inc.07/05/2023SE
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmKRA · Traditional Vvt Medical , Ltd.06/20/2023SE
K230957TriSalus TriNav® LV Infusion SystemKRA · Traditional Trisalus Life Sciences05/02/2023SE
K223139Wallaby 017 Micro CatheterKRA · Traditional Wallaby Medical04/25/2023SE

More from Wallaby Medical

510(k)DeviceDecision
K082163Flowmedica Benephit Infusion SystemsKRA · Traditional 10/29/2008SE
K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathKRA · Traditional 01/13/2004SE

Questions and answers

When was Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath cleared by the FDA?

Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath (K050205) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 35 days after the submission was received.

What is the product code of K050205?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.