FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTENSION SET W/INJECTION SITE
K Number: K842984
·
Decision Oct 16, 1984
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
22
Review Days
78
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Basic Information
- Device Name
- EXTENSION SET W/INJECTION SITE
- K Number
- K842984
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Med Fusion Systems, Inc.
- Date Received
- July 30, 1984
- Decision Date
- October 16, 1984
- 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 Med Fusion Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | Dec 29, 1987 | Substantially Equivalent |
| K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR | May 6, 1987 | Substantially Equivalent |
| K870907 | INTRODUCER, PERCUTANEOUS | Apr 9, 1987 | Substantially Equivalent |
| K864407 | REFILLABLE SYRINGE | Jan 20, 1987 | Substantially Equivalent |
| K863814 | BAG SPIKE EXTENSION SET | Oct 14, 1986 | Substantially Equivalent |
| K860616 | VOLUME CONTROL SET WITH EXTENSION | Jun 2, 1986 | Substantially Equivalent |
| K860803 | IV FILTER EXTENSION SET | Apr 9, 1986 | Substantially Equivalent |
| K844313 | INFUSET W/HUBER NEEDLE | Jan 22, 1985 | Substantially Equivalent |
| K842143 | BENT WINGED MINI-VOL INFUSION SET | Jul 20, 1984 | Substantially Equivalent |
| K841882 | THREE WAY INFUSION SET | Jun 5, 1984 | Substantially Equivalent |