FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLITAIRE FR REVASCULARIZATION DEVICE
K Number: K113455
·
Decision Mar 2, 2012
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
3
Review Days
102
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SOLITAIRE FR REVASCULARIZATION DEVICE
- K Number
- K113455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics Dba Ev3 Neurovascular
- Date Received
- November 21, 2011
- Decision Date
- March 2, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NRY), ordered by most recent decision date.
Penumbra System (Thunderbolt Aspiration Tubing)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Lynx Aspiration Catheter System
FDA 510(k)
FDA Class 2
·Cardiovascular
Millipede System
FDA 510(k)
FDA Class 2
·Cardiovascular
Tigertriever 25 Revascularization Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Esperance pHLO Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular