FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTFLOW CATHETER
K Number: K123605
·
Decision Aug 16, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
14
Review Days
268
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Basic Information
- Device Name
- SMARTFLOW CATHETER
- K Number
- K123605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Interventions, Inc.
- Date Received
- November 21, 2012
- Decision Date
- August 16, 2013
- Product Code
- HCA
- 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 |
|---|---|---|---|
| HCA | Catheter, Ventricular | FDA class 2 | Neurology |
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