FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Captus Vascular Retrieval System
K Number: K170987
·
Decision Aug 28, 2017
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
31
Applicant Total
2
Review Days
147
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Basic Information
- Device Name
- Captus Vascular Retrieval System
- K Number
- K170987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avantec Vascular Corporation
- Date Received
- April 3, 2017
- Decision Date
- August 28, 2017
- Product Code
- MMX
- 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 |
|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | FDA class 2 | Cardiovascular |
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Other Clearances by Avantec Vascular Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251207 | Sangria Thrombectomy System | Jan 7, 2026 | Substantially Equivalent |