FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CLINISET INFUSION SET
K Number: K860322
·
Decision Apr 7, 1986
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
17
Review Days
68
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Basic Information
- Device Name
- CLINISET INFUSION SET
- K Number
- K860322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Zimmar Consulting , Ltd.
- Date Received
- January 29, 1986
- Decision Date
- April 7, 1986
- 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 Zimmar Consulting , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K843477 | PHARMA-PLAST RECTAL TIP | Dec 5, 1984 | Substantially Equivalent |
| K843478 | PHARMA-PLAST URIDROP-URIDOME | Dec 5, 1984 | Substantially Equivalent |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | Nov 23, 1984 | Substantially Equivalent |
| K843469 | PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- | Nov 19, 1984 | Substantially Equivalent |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | Nov 19, 1984 | Substantially Equivalent |
| K843467 | PHARMA-PLAST NASAL OXYGEN CANNULA | Nov 19, 1984 | Substantially Equivalent |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | Nov 16, 1984 | Substantially Equivalent |
| K843475 | PHARMA-PLAST SINGLE USE OVERSHOES | Oct 31, 1984 | Substantially Equivalent |
| K843471 | PHARMA-PLAST SYRINGE | Oct 31, 1984 | Substantially Equivalent |
| K843473 | PHARMA-PLAST INSULIN SYRINGE | Oct 31, 1984 | Substantially Equivalent |