FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-DRIP INFUSION CATHETER
K Number: K042246
·
Decision Aug 31, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- MULTI-DRIP INFUSION CATHETER
- K Number
- K042246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Infusion, Inc.
- Date Received
- August 19, 2004
- Decision Date
- August 31, 2004
- Product Code
- MEB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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Other Clearances by Advanced Infusion, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Feb 19, 2008 | Substantially Equivalent |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Oct 18, 2006 | Substantially Equivalent |
| K061356 | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 | Jul 3, 2006 | Substantially Equivalent |
| K021964 | ALPHA INFUSION PUMP AND CATHETERS | Aug 12, 2002 | Substantially Equivalent |
| K992551 | ALPHA INFUSION PUMP | Oct 27, 1999 | Substantially Equivalent |