FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUTE HEMODIALYSIS TRAYS
K Number: K844612
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
13
Review Days
20
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Basic Information
- Device Name
- ACUTE HEMODIALYSIS TRAYS
- K Number
- K844612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Packaging Technologies, Inc.
- Date Received
- November 27, 1984
- Decision Date
- December 17, 1984
- Product Code
- KNZ
- 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 |
|---|---|---|---|
| KNZ | Accessories, A-V Shunt | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNZ), ordered by most recent decision date.
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
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VACCESS FEMORAL CANNULA
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DUO FLOW CATHETER-MC 54
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DOUBLE LUMEN SUBLCAVIAN-FEMORAL
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TOPS DISPOS. INFUSION SET/HEMODIALYSIS
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FDA Class 2
·Gastroenterology, Urology
HEMOCATH REPAIR KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Packaging Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881756 | STERILE SURGEONS GLOVES | Jun 1, 1988 | Substantially Equivalent |
| K863326 | BONE MARROW TRAY | Sep 16, 1986 | Substantially Equivalent |
| K861041 | ENHANCE | May 30, 1986 | Substantially Equivalent |
| K850544 | SHAVE PREP TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850438 | RENAL BIOPSY TRAY | Feb 26, 1985 | Substantially Equivalent |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Jan 10, 1985 | Substantially Equivalent |
| K844611 | SINGLE BASIN SET | Dec 19, 1984 | Substantially Equivalent |
| K844614 | IV START KIT | Dec 19, 1984 | Substantially Equivalent |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | Mar 19, 1984 | Substantially Equivalent |
| K834073 | CENTRAL VEIN CATHERIZATION TRAY CC-20 | Feb 28, 1984 | Substantially Equivalent |