FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CAPD DISPOSABLE Y SYSTEM - DY SET
K Number: K883393
·
Decision Nov 3, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
6
Review Days
86
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Basic Information
- Device Name
- CAPD DISPOSABLE Y SYSTEM - DY SET
- K Number
- K883393
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medionics International , Ltd.
- Date Received
- August 9, 1988
- Decision Date
- November 3, 1988
- 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
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Other Clearances by Medionics International , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K910173 | SELECTRA AND TUBING SETS | Jan 13, 1992 | Substantially Equivalent |
| K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 | Jun 25, 1984 | Substantially Equivalent |
| K831766 | MICROSTAR VCI | Oct 14, 1983 | Substantially Equivalent |
| K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER | Oct 14, 1983 | Substantially Equivalent |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Jul 28, 1982 | Substantially Equivalent |