FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPERE Thrombectomy System
K Number: K203476
·
Decision Dec 22, 2020
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- CAPERE Thrombectomy System
- K Number
- K203476
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Medcure, Inc.
- Date Received
- November 25, 2020
- Decision Date
- December 22, 2020
- 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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Other Clearances by Vascular Medcure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201216 | CAPERE Thrombectomy System | Jul 8, 2020 | Substantially Equivalent |
| K200314 | Capere Thrombectomy System | Mar 4, 2020 | Substantially Equivalent |
| K192935 | CAPERE Thrombectomy System | Nov 15, 2019 | Substantially Equivalent |
| K183179 | CAPERE Thrombectomy System | Feb 25, 2019 | Substantially Equivalent |