IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

FDA 510(k) K192289 · Irras USA, Ltd.

Substantially Equivalent

510(k) numberK192289

Submission

Device name
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Applicant
Irras USA, Ltd.
San Diego, CA, US
Received
August 23, 2019
Decision date
November 15, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

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More from Aesculap, Inc.

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K231664IRRAflow Active Fluid Exchange System (AFES)JXG · Traditional 10/19/2023SE
K222471IRRAflow Active Fluid Exchange System (AFES)JXG · Special 12/08/2022SE
K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Special 04/29/2020SE

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 (K192289) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 84 days after the submission was received.

What is the product code of K192289?

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