FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
K Number: K102101
·
Decision Jan 26, 2011
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
2
Applicant Total
4
Review Days
183
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Basic Information
- Device Name
- SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
- K Number
- K102101
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4060
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgivision, Inc.
- Date Received
- July 27, 2010
- Decision Date
- January 26, 2011
- Product Code
- HCD
- 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 |
|---|---|---|---|
| HCD | Cannula, Ventricular | FDA class 1 | Neurology |
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