FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K Number: K093973
·
Decision May 26, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
152
Review Days
153
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Basic Information
- Device Name
- TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K Number
- K093973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- December 24, 2009
- Decision Date
- May 26, 2010
- 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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