CSF400 and CSF600

FDA 510(k) K030081 · Inmed Ltda.

Substantially Equivalent

510(k) numberK030081

Submission

Device name
CSF400 and CSF600
Applicant
Inmed Ltda.
Alpharetta, GA, US
Received
January 9, 2003
Decision date
October 6, 2003
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 CSF400 and CSF600 cleared by the FDA?

CSF400 and CSF600 (K030081) received a 510(k) decision of Substantially Equivalent on October 6, 2003, 270 days after the submission was received.

What is the product code of K030081?

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