Aesculap - Meithke Progav 2.0 Adjustable Shunt System
FDA 510(k) K141687 · Aesculap, Inc.
510(k) numberK141687
Submission
- Device name
- Aesculap - Meithke Progav 2.0 Adjustable Shunt System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- June 12, 2014
- Decision date
- April 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aesculap - Meithke Progav 2.0 Adjustable Shunt System cleared by the FDA?
Aesculap - Meithke Progav 2.0 Adjustable Shunt System (K141687) received a 510(k) decision of Substantially Equivalent on April 2, 2015, 294 days after the submission was received.
What is the product code of K141687?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.