FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
K Number: K896600
·
Decision Mar 22, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
112
Applicant Total
62
Review Days
121
Basic Information
- Device Name
- DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
- K Number
- K896600
- 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
- November 21, 1989
- Decision Date
- March 22, 1990
- 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 |
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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 |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | Sep 21, 1992 | Substantially Equivalent |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | 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 |
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | Sep 21, 1992 | Substantially Equivalent |