FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPD EXCHANGE SET
K Number: K810600
·
Decision Mar 24, 1981
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
13
Review Days
18
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Basic Information
- Device Name
- CAPD EXCHANGE SET
- K Number
- K810600
- 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 6, 1981
- Decision Date
- March 24, 1981
- Product Code
- KDJ
- 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
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staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
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Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
FDA 510(k)
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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 |