FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATI PLASMA PUMP (PP-04)
K Number: K961137
·
Decision Jun 14, 1996
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- ATI PLASMA PUMP (PP-04)
- K Number
- K961137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Apheresis Technologies, Inc.
- Date Received
- March 21, 1996
- Decision Date
- June 14, 1996
- Product Code
- FIR
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIR | Pump, Blood, Extra-Luminal | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Apheresis Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926409 | PLASMA DISCARD BAGS | Mar 2, 1993 | Substantially Equivalent |