FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GANZ CORONARY REPERFUSION CATHETER
K Number: K803270
·
Decision Mar 27, 1981
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
89
Review Days
88
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Basic Information
- Device Name
- GANZ CORONARY REPERFUSION CATHETER
- K Number
- K803270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- December 29, 1980
- Decision Date
- March 27, 1981
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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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 |