FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTECTED NEEDLE WITH OR WITHOUT IV SET
K Number: K903809
·
Decision Oct 3, 1990
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
44
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Basic Information
- Device Name
- PROTECTED NEEDLE WITH OR WITHOUT IV SET
- K Number
- K903809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kendall Mcgaw Laboratories, Inc.
- Date Received
- August 20, 1990
- Decision Date
- October 3, 1990
- 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 Kendall Mcgaw Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905610 | MICRORATE INTELLIGENT PUMP | Mar 1, 1991 | Substantially Equivalent |
| K905611 | MICRORATE PLUS INTELLIGENT PUMP | Mar 1, 1991 | Substantially Equivalent |
| K904855 | ADD-A-VIAL | Nov 19, 1990 | Substantially Equivalent |
| K904518 | VOLUMETRIC INFUSION PUMP | Oct 17, 1990 | Substantially Equivalent |
| K901065 | INFUSION PUMP | Aug 21, 1990 | Substantially Equivalent |
| K900865 | ADD-A-VIAL II BINARY CONNECTOR | Jul 11, 1990 | Substantially Equivalent |
| K896292 | 1.2 MICRON FILTER WITH IV SET | Dec 8, 1989 | Substantially Equivalent |
| K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | Sep 27, 1989 | Substantially Equivalent |
| K882159 | 522 INTELLIGENT PUMP | Aug 24, 1988 | Substantially Equivalent |
| K874467 | SET, ADMINISTRATION INTRAVASCULAR | Jan 6, 1988 | Substantially Equivalent |