FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVAC BALL VALCE ADMIN. SETS
K Number: K953225
·
Decision Sep 27, 1995
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
78
Review Days
79
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Basic Information
- Device Name
- IVAC BALL VALCE ADMIN. SETS
- K Number
- K953225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Y
- Date Received
- July 10, 1995
- Decision Date
- September 27, 1995
- 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 Y
| K Number | Device Name | ||
|---|---|---|---|
| K955846 | MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER | Oct 1, 1996 | Substantially Equivalent |
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS | Apr 4, 1996 | Substantially Equivalent |
| K934095 | IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS | Aug 10, 1994 | Substantially Equivalent |
| K940897 | IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET | Jun 22, 1994 | Substantially Equivalent |
| K931550 | EZ ADMINISTRATION SET | Jan 10, 1994 | Substantially Equivalent |
| K931549 | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP | Oct 12, 1993 | Substantially Equivalent |
| K932544 | IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 | Oct 12, 1993 | Substantially Equivalent |
| K922115 | IVAC NEEDLELESS INJECTION VALVE | Oct 12, 1993 | Substantially Equivalent |
| K930781 | INFUSION PUMP | Aug 19, 1993 | Substantially Equivalent |
| K925228 | IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL | Jul 30, 1993 | Substantially Equivalent |