FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
IV TRANSFER SPIKE
K Number: K943095
·
Decision Sep 30, 1994
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
15
Review Days
94
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Basic Information
- Device Name
- IV TRANSFER SPIKE
- K Number
- K943095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Migada, Ltd.
- Date Received
- June 28, 1994
- Decision Date
- September 30, 1994
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Migada, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K854365 | IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS | Mar 24, 1986 | Substantially Equivalent |
| K860605 | FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER | Mar 24, 1986 | Substantially Equivalent |