FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K Number: K810162
·
Decision Feb 4, 1981
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
89
Review Days
13
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
- FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
- K Number
- K810162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- January 22, 1981
- Decision Date
- February 4, 1981
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXC), ordered by most recent decision date.
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
FDA 510(k)
FDA Class 2
·Cardiovascular
Arc Adjustable Radial Cuff Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Life Saving Tourniquet
FDA 510(k)
FDA Class 2
·Cardiovascular
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Radial Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by American Edwards Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K873485 | EDSLAB (R) OCCLUSION BALLOON CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K872596 | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 | Sep 30, 1987 | Substantially Equivalent |
| K872529 | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 | Sep 15, 1987 | Substantially Equivalent |
| K870444 | HOMEPRO II VOLUMETRIC INFUSION PUMP | Apr 17, 1987 | Substantially Equivalent |
| K864997 | MEDTRAC VP VOLUMETRIC INFUSION PUMP | Feb 27, 1987 | Substantially Equivalent |
| K864330 | SHEAR FORCE GAUGE | Jan 6, 1987 | Substantially Equivalent |
| K862724 | VEIN VALVE CUTTER | Jan 2, 1987 | Substantially Equivalent |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | Nov 20, 1986 | Substantially Equivalent |
| K863596 | CHIN-FOGARTY INFLATION DEVICE | Nov 20, 1986 | Substantially Equivalent |
| K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES | Oct 31, 1986 | Substantially Equivalent |