FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I.V. ADMINISTRATION SET
K Number: K926448
·
Decision May 2, 1994
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
495
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Basic Information
- Device Name
- I.V. ADMINISTRATION SET
- K Number
- K926448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gainor Medical Europe, Ltd.
- Date Received
- December 23, 1992
- Decision Date
- May 2, 1994
- 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 Gainor Medical Europe, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931828 | CARELET SAFETY LANCET | Oct 15, 1993 | Substantially Equivalent |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Sep 13, 1993 | Substantially Equivalent |
| K922441 | SURESEAL BANDAGE | Aug 10, 1993 | Substantially Equivalent |
| K913333 | I.V. PRIMING SET | Oct 23, 1991 | Substantially Equivalent |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | Jun 6, 1991 | Substantially Equivalent |
| K902420 | CATHETER, NASAL, OXYGEN | Apr 17, 1991 | Substantially Equivalent |
| K902564 | NEEDLE, DIALYSIS | Mar 1, 1991 | Substantially Equivalent |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Nov 20, 1990 | Substantially Equivalent |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Nov 20, 1990 | Substantially Equivalent |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Aug 1, 1990 | Substantially Equivalent |