FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFUSE-A-PORT HEPARIN LOCK MAINT KIT
K Number: K840481
·
Decision Sep 18, 1984
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
8
Review Days
225
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Basic Information
- Device Name
- INFUSE-A-PORT HEPARIN LOCK MAINT KIT
- K Number
- K840481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Infusaid Corp.
- Date Received
- February 6, 1984
- Decision Date
- September 18, 1984
- Product Code
- LJT
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Infusaid Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K910448 | SNAP-LOCK MICRO PORT, MODIFICATION | Nov 21, 1991 | Substantially Equivalent |
| K901419 | DUAL PORT | Sep 5, 1990 | Substantially Equivalent |
| K902251 | SUBCLAVIAN INTRODUCER SET | Jul 31, 1990 | Substantially Equivalent |
| K860898 | SUBCLAVIAN INTRODUCER SET | Apr 29, 1986 | Substantially Equivalent |
| K842355 | INFUSAID INFUSE-A-PORT | Aug 6, 1984 | Substantially Equivalent |
| K832788 | INFUSE-A-PORT | Sep 15, 1983 | Substantially Equivalent |
| K823838 | INFUSE-A-PORT | Jan 12, 1983 | Substantially Equivalent |