Low Flow Osv II Hydrocephalus Valve

FDA 510(k) K042192 · Integra Neurosciences Implants S.A.

Substantially Equivalent

510(k) numberK042192

Submission

Device name
Low Flow Osv II Hydrocephalus Valve
Applicant
Integra Neurosciences Implants S.A.
Planisboro, NJ, US
Received
August 12, 2004
Decision date
September 2, 2004
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

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More from Aesculap, Inc.

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K081773Osv IIJXG · Special 11/06/2008SE
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K040201Modification to Burr Hole Valve and Shunt SystemJXG · Special 02/26/2004SE
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Questions and answers

When was Low Flow Osv II Hydrocephalus Valve cleared by the FDA?

Low Flow Osv II Hydrocephalus Valve (K042192) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 21 days after the submission was received.

What is the product code of K042192?

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