FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICHOR 7F Embolectomy System (ICH-7F)
K Number: K233917
·
Decision Jul 18, 2024
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
2
Review Days
219
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Basic Information
- Device Name
- ICHOR 7F Embolectomy System (ICH-7F)
- K Number
- K233917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ichor
- Date Received
- December 12, 2023
- Decision Date
- July 18, 2024
- 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 Ichor
| K Number | Device Name | ||
|---|---|---|---|
| K230743 | ICHOR 14F Embolectomy System | Sep 5, 2023 | Substantially Equivalent |