FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARRICADE EMBOLIZATION COIL SYSTEM
K Number: K131475
·
Decision Jul 25, 2013
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
6
Review Days
64
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Basic Information
- Device Name
- BARRICADE EMBOLIZATION COIL SYSTEM
- K Number
- K131475
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blockade Medical
- Date Received
- May 22, 2013
- Decision Date
- July 25, 2013
- Product Code
- HCG
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by Blockade Medical
| K Number | Device Name | ||
|---|---|---|---|
| K151760 | Barricade Embolization Coil System | Jul 27, 2015 | Substantially Equivalent |
| K142513 | Barricade Embolization Coil System | Nov 13, 2014 | Substantially Equivalent |
| K140104 | BARRICADE EMBOLIZATION COIL SYSTEM | Feb 13, 2014 | Substantially Equivalent |
| K132482 | BARRICADE EMBOLIZATION COIL SYSTEM | Oct 10, 2013 | Substantially Equivalent |
| K123338 | BARRICADE EMBOLIZATION COIL SYSTEM | Mar 28, 2013 | Substantially Equivalent |