FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETCH 2 ASPIRATION CATHETER MODEL 109400-001
K Number: K101354
·
Decision Jan 21, 2011
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
2
Review Days
252
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Basic Information
- Device Name
- FETCH 2 ASPIRATION CATHETER MODEL 109400-001
- K Number
- K101354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medrad Interventional/Possis
- Date Received
- May 14, 2010
- Decision Date
- January 21, 2011
- Product Code
- QEZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Medrad Interventional/Possis
| K Number | Device Name | ||
|---|---|---|---|
| K101406 | ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 | Jun 16, 2010 | Substantially Equivalent |