FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The ICHOR Panacea Vascular Embolectomy Catheter System
K Number: K182167
·
Decision Dec 21, 2018
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
1
Review Days
133
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Basic Information
- Device Name
- The ICHOR Panacea Vascular Embolectomy Catheter System
- K Number
- K182167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ichor Vascular, Inc.
- Date Received
- August 10, 2018
- Decision Date
- December 21, 2018
- 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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