FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBOLECTOMY CATHETER(MODIFIED)
K Number: K881455
·
Decision Jun 15, 1988
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
73
Applicant Total
8
Review Days
70
Basic Information
- Device Name
- EMBOLECTOMY CATHETER(MODIFIED)
- K Number
- K881455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CATHLAB CORP.
- Date Received
- April 6, 1988
- Decision Date
- June 15, 1988
- 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 Venous Thrombectomy Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Arterial Embolectomy Catheter with Gate Valve
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 CATHLAB CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | Aug 2, 1991 | Substantially Equivalent |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Jun 24, 1991 | Substantially Equivalent |
| K905139 | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER | Feb 25, 1991 | Substantially Equivalent |
| K897051 | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH | Mar 16, 1990 | Substantially Equivalent |
| K897184 | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS | Mar 14, 1990 | Substantially Equivalent |
| K893435 | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER | Sep 26, 1989 | Substantially Equivalent |
| K893680 | SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. | Aug 1, 1989 | Substantially Equivalent |