IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

FDA 510(k) K200807 · Irras USA, Inc.

Substantially Equivalent

510(k) numberK200807

Submission

Device name
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Applicant
Irras USA, Inc.
San Diego, CA, US
Received
March 27, 2020
Decision date
April 29, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code JXG

510(k)DeviceApplicantDecision
K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional Integra Lifesciences Production Corporation06/23/2026SE
K251598IntellidropJXG · Traditional Brainspace, Inc.12/10/2025SE
K250636Sophy Mini Monopressure Valve (SM1)JXG · Traditional Sophysa11/28/2025SE
K252514Evac-MriJXG · Traditional Phasor Health, LLC11/05/2025SESD
K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional Integra Lifesciences Production Corporation08/08/2025SE
K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional Integra Lifesciences Production Corporation08/06/2025SE
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional Sophysa06/20/2025SE
K243205EvacJXG · Traditional Phasor Health, LLC06/03/2025SE
K243676Duet External Drainage and Monitoring System (EDMS)JXG · Traditional Medtronic Neurosurgery03/10/2025SE
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional Aesculap, Inc.12/16/2024SE

More from Aesculap, Inc.

510(k)DeviceDecision
K231664IRRAflow Active Fluid Exchange System (AFES)JXG · Traditional 10/19/2023SE
K222471IRRAflow Active Fluid Exchange System (AFES)JXG · Special 12/08/2022SE
K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Traditional 11/15/2019SE

Questions and answers

When was IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit cleared by the FDA?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K200807) received a 510(k) decision of Substantially Equivalent on April 29, 2020, 33 days after the submission was received.

What is the product code of K200807?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.