FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking & PMS
🇺🇸 United States
PROSTHETIC RINGS #4400 MITRAL & 4500
K Number: K831949
·
Decision Jul 29, 1983
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
89
Review Days
43
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Basic Information
- Device Name
- PROSTHETIC RINGS #4400 MITRAL & 4500
- K Number
- K831949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Applicant
- American Edwards Laboratories
- Date Received
- June 16, 1983
- Decision Date
- July 29, 1983
- Product Code
- KRH
- 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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | FDA class 2 | Cardiovascular |
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Other Clearances by American Edwards Laboratories
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |