FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K Number: K850015
·
Decision Jun 19, 1985
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
2
Review Days
168
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
- POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
- K Number
- K850015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Polymed Laboratories
- Date Received
- January 2, 1985
- Decision Date
- June 19, 1985
- 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
Merlin Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Polymed Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K862124 | POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER | Aug 14, 1986 | Substantially Equivalent |