MIETHKE SHUNT SYSTEM
FDA 510(k) clearance K020728 · decided 2002-04-05
Clearance details
- K-number
- K020728
- Device name
- MIETHKE SHUNT SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-06
- Decision date
- 2002-04-05
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HCA
- Device class
- 2
- Regulation number
- 882.4100
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and F recall (Z-0805-2013) | Aesculap, Inc. | 2013-02-12 |