FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
K Number: K900295
·
Decision Nov 21, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
5
Review Days
303
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Basic Information
- Device Name
- PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
- K Number
- K900295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Microwave Medical Systems, Inc.
- Date Received
- January 22, 1990
- Decision Date
- November 21, 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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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 Microwave Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974387 | PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE | Sep 1, 1999 | Substantially Equivalent |
| K932083 | XDCS-100 | Dec 16, 1993 | Substantially Equivalent |
| K914867 | QWIK-1(TM) IN-LINE IV FLUID WARMER | Oct 23, 1992 | Substantially Equivalent |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Oct 10, 1991 | Substantially Equivalent |