Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters

FDA 510(k) K033704 · Vygon Us, LLC

Substantially Equivalent

510(k) numberK033704

Submission

Device name
Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters
Applicant
Vygon Us, LLC
Norristown, PA, US
Received
November 25, 2003
Decision date
May 27, 2004
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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 Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters cleared by the FDA?

Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage Catheters (K033704) received a 510(k) decision of Substantially Equivalent on May 27, 2004, 184 days after the submission was received.

What is the product code of K033704?

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