FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Merlin Aspiration System
K Number: K213771
·
Decision Jan 27, 2022
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
1
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Merlin Aspiration System
- K Number
- K213771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mivi Neurovascular, Inc.
- Date Received
- December 2, 2021
- Decision Date
- January 27, 2022
- Product Code
- DXE
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXE), ordered by most recent decision date.
Fogarty Thru-Lumen Embolectomy Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Fortis Arterial Embolectomy Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Arterial Embolectomy Catheter with Gate Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Venous Thrombectomy Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular