Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac

FDA 510(k) K121248 · Moller Medical GmbH

Substantially Equivalent

510(k) numberK121248

Submission

Device name
Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac
Applicant
Moller Medical GmbH
Corona, CA, US
Received
April 25, 2012
Decision date
December 13, 2013
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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Questions and answers

When was Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac cleared by the FDA?

Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac (K121248) received a 510(k) decision of Substantially Equivalent on December 13, 2013, 597 days after the submission was received.

What is the product code of K121248?

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