FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
K Number: K200871
·
Decision May 4, 2020
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
2
Review Days
33
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Basic Information
- Device Name
- Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
- K Number
- K200871
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Control Medical Technology
- Date Received
- April 1, 2020
- Decision Date
- May 4, 2020
- 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 Control Medical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K200629 | Aspire Mechanical Aspirator G | May 29, 2020 | Substantially Equivalent |