FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFELINE MULTIDOSE VIAL ADAPTER
K Number: K955595
·
Decision Mar 6, 1996
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
13
Review Days
89
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Basic Information
- Device Name
- SAFELINE MULTIDOSE VIAL ADAPTER
- K Number
- K955595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mcgaw, Inc.
- Date Received
- December 8, 1995
- Decision Date
- March 6, 1996
- 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 Mcgaw, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | Oct 7, 1997 | Substantially Equivalent |
| K955594 | SAFELINE I.V. BAG ACCESS DEVICE | Mar 6, 1996 | Substantially Equivalent |
| K941244 | SAFELINE SYSTEM TURN LOCK CANNULA | Nov 29, 1994 | Substantially Equivalent |
| K932165 | INTRAVASCULAR ADMINISTRATION SET | Apr 13, 1994 | Substantially Equivalent |
| K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | Mar 7, 1994 | Substantially Equivalent |
| K932856 | IRRIGATION ACCESS CAP | Jan 26, 1994 | Substantially Equivalent |
| K922637 | HORIZON PUMP Y-TYPE BLOOD SET | Jun 4, 1993 | Substantially Equivalent |
| K921860 | MODIFICATION TO IV SPIKE | Jul 30, 1992 | Substantially Equivalent |
| K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | Dec 18, 1991 | Substantially Equivalent |
| K913056 | VOLUMETRIC INFUSION PUMP, MODIFICATION | Sep 6, 1991 | Substantially Equivalent |