FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHIN-FOGARTY INFLATION DEVICE
K Number: K863596
·
Decision Nov 20, 1986
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
89
Review Days
66
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Basic Information
- Device Name
- CHIN-FOGARTY INFLATION DEVICE
- K Number
- K863596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- September 15, 1986
- Decision Date
- November 20, 1986
- Product Code
- DXT
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
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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 |
| K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES | Oct 31, 1986 | Substantially Equivalent |
| K862872 | FLEXIBLE VISUALIZATION CATHETER | Oct 24, 1986 | Substantially Equivalent |