Miethke Shunt System
FDA 510(k) K020728 · Aesculap, Inc.
510(k) numberK020728
Submission
- Device name
- Miethke Shunt System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- March 6, 2002
- Decision date
- April 5, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Miethke Shunt System cleared by the FDA?
Miethke Shunt System (K020728) received a 510(k) decision of Substantially Equivalent on April 5, 2002, 30 days after the submission was received.
What is the product code of K020728?
The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.