FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTION SITE #014456-120
K Number: K870913
·
Decision Mar 17, 1987
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
10
Review Days
11
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Basic Information
- Device Name
- INJECTION SITE #014456-120
- K Number
- K870913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Clinical Connections, Inc.
- Date Received
- March 6, 1987
- Decision Date
- March 17, 1987
- 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 Clinical Connections, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884435 | RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS | Nov 8, 1988 | Substantially Equivalent |
| K871540 | SWIVEL CONNECTORS #014452/#014453/#014459-120 | Apr 30, 1987 | Substantially Equivalent |
| K870325 | #014160-TAB TUBING ROTATOR ADAPTOR | Apr 27, 1987 | Substantially Equivalent |
| K870477 | DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y | Apr 3, 1987 | Substantially Equivalent |
| K870912 | T-CONNECTORS 014500/014501/014502/014503-120 | Mar 17, 1987 | Substantially Equivalent |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK | Mar 13, 1987 | Substantially Equivalent |
| K870394 | HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS | Mar 3, 1987 | Substantially Equivalent |
| K870073 | MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB | Feb 20, 1987 | Substantially Equivalent |
| K870326 | VARIOUS LUER AND TUBING FITTINGS | Feb 10, 1987 | Substantially Equivalent |