FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSASAE PLASTIC CANNULA- 11 GAUGE
K Number: K945070
·
Decision Jan 13, 1995
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
43
Review Days
91
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Basic Information
- Device Name
- VERSASAE PLASTIC CANNULA- 11 GAUGE
- K Number
- K945070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imed Corp.
- Date Received
- October 14, 1994
- Decision Date
- January 13, 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 Imed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960512 | GEMINI PC-ITX | Nov 21, 1996 | Substantially Equivalent |
| K953896 | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS | Mar 20, 1996 | Substantially Equivalent |
| K950153 | VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES | Aug 24, 1995 | Substantially Equivalent |
| K951922 | ADMINISTRATION SETS WITH BALL FLOAT | Jul 19, 1995 | Substantially Equivalent |
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS | Jun 21, 1995 | Substantially Equivalent |
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | Feb 14, 1995 | Substantially Equivalent |
| K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH | Apr 15, 1994 | Substantially Equivalent |
| K933144 | GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER | Oct 12, 1993 | Substantially Equivalent |
| K924718 | SHROUDED NEEDLE DEVICES | Jun 18, 1993 | Substantially Equivalent |
| K921378 | IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE | Jun 9, 1992 | Substantially Equivalent |