FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
K Number: K083370
·
Decision Dec 12, 2008
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
1
Review Days
28
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Basic Information
- Device Name
- D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
- K Number
- K083370
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Artegraft, Inc.
- Date Received
- November 14, 2008
- Decision Date
- December 12, 2008
- Product Code
- QEW
- 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 |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
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