FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Medtronic DUET External Drainage and Monitoring System
K Number: DEN120017
·
Decision Aug 22, 2014
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
1
Applicant Total
28
Review Days
609
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Basic Information
- Device Name
- Medtronic DUET External Drainage and Monitoring System
- K Number
- DEN120017
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 882.5560
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Medtronic Neurosurgery
- Date Received
- December 21, 2012
- Decision Date
- August 22, 2014
- Product Code
- PCB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PCB | External Cerebrospinal Fluid (Csf) Diversion | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PCB), ordered by most recent decision date.
View allOther Clearances by Medtronic Neurosurgery
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| K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER | Nov 18, 2011 | Substantially Equivalent |
| K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | Sep 2, 2009 | Substantially Equivalent |
| K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 | Nov 20, 2008 | Substantially Equivalent |