FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
K Number: K892872
·
Decision May 18, 1989
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
62
Review Days
29
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Basic Information
- Device Name
- PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
- K Number
- K892872
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Date Received
- April 19, 1989
- Decision Date
- May 18, 1989
- 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
Other 510(k) clearances with the same product code (KDJ), ordered by most recent decision date.
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 National Medical Care, Medical Products Div., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | Nov 1, 1996 | Substantially Equivalent |
| K941757 | FORMALIN REUSE CART | Jan 22, 1996 | Substantially Equivalent |
| K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER | Dec 22, 1995 | Substantially Equivalent |
| K930843 | RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 | Aug 31, 1994 | Substantially Equivalent |
| K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R | Mar 5, 1993 | Substantially Equivalent |
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | Sep 21, 1992 | Substantially Equivalent |
| K920586 | DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET | Sep 21, 1992 | Substantially Equivalent |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | Sep 21, 1992 | Substantially Equivalent |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | Sep 21, 1992 | Substantially Equivalent |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | Sep 21, 1992 | Substantially Equivalent |