FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPD CATHETER ADAPTER
K Number: K810683
·
Decision May 8, 1981
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
13
Review Days
56
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Basic Information
- Device Name
- CAPD CATHETER ADAPTER
- K Number
- K810683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Mcgaw
- Date Received
- March 13, 1981
- Decision Date
- May 8, 1981
- Product Code
- FKX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKX), ordered by most recent decision date.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
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Other Clearances by American Mcgaw
| K Number | Device Name | ||
|---|---|---|---|
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | Nov 12, 1985 | Substantially Equivalent |
| K843639 | ADD-A-VIAL SOLUTION TRANSFER DEVICE | Jan 14, 1985 | Substantially Equivalent |
| K843954 | MIXING CONTAINER | Nov 28, 1984 | Substantially Equivalent |
| K841729 | ACCUPRO ENTERAL FEEDING PUMP | Jun 1, 1984 | Substantially Equivalent |
| K840212 | CONCENTRATED PLATELET ADMIN. SET | Mar 6, 1984 | Substantially Equivalent |
| K840388 | PAB IV CONTAINER | Mar 6, 1984 | Substantially Equivalent |
| K831716 | CAPD - CATHETER ADAPTER | Jun 24, 1983 | Substantially Equivalent |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | Dec 30, 1982 | Substantially Equivalent |
| K820133 | MCGAW FAT EMULSION SET | Apr 6, 1982 | Substantially Equivalent |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | Dec 31, 1981 | Substantially Equivalent |