FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS
K Number: K854365
·
Decision Mar 24, 1986
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
15
Review Days
146
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Basic Information
- Device Name
- IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS
- K Number
- K854365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Migada, Ltd.
- Date Received
- October 29, 1985
- Decision Date
- March 24, 1986
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Migada, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K943095 | IV TRANSFER SPIKE | Sep 30, 1994 | Substantially Equivalent |
| K933929 | LAB-SITE(R) SAFETY CANNULA | Dec 7, 1993 | Substantially Equivalent |
| K902881 | LAB-SITE SAFETY NEEDLE | Sep 26, 1990 | Substantially Equivalent |
| K870016 | ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) | May 28, 1987 | Substantially Equivalent |
| K864453 | EMERGENCY & MILITARY INFUSION SYSTEM | Jan 20, 1987 | Substantially Equivalent |
| K863304 | PRESELECTED FLOW RATE I.V. SET | Dec 9, 1986 | Substantially Equivalent |
| K860952 | I.V. SET WITH AND WITHOUT AIR VENT | Aug 27, 1986 | Substantially Equivalent |
| K861275 | HIGH FLOW I.V. SET | Jun 2, 1986 | Substantially Equivalent |
| K860595 | TRANSFER SET | Apr 7, 1986 | Substantially Equivalent |
| K860605 | FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER | Mar 24, 1986 | Substantially Equivalent |