FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLITAIRE 2 REVASCULARIZATION DEVICE
K Number: K123378
·
Decision Nov 30, 2012
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- SOLITAIRE 2 REVASCULARIZATION DEVICE
- K Number
- K123378
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics Dba Ev3 Neurovascular
- Date Received
- November 1, 2012
- Decision Date
- November 30, 2012
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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