FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKCAT EXTRACTION CATHETER
K Number: K060092
·
Decision Mar 9, 2006
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
19
Review Days
56
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Basic Information
- Device Name
- QUICKCAT EXTRACTION CATHETER
- K Number
- K060092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kensey Nash Corp.
- Date Received
- January 12, 2006
- Decision Date
- March 9, 2006
- 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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|---|---|---|---|
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| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | Jun 1, 2007 | Substantially Equivalent |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Oct 20, 2006 | Substantially Equivalent |