Product Code: FIR
FDA class 2
21 CFR 876.5820
Pump, Blood, Extra-Luminal
Gastroenterology, Urology
The Extra-Luminal Blood Pump is a pump component positioned outside the blood tubing in a hemodialysis circuit to propel blood through the extracorporeal system at a controlled flow rate. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIR, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
510(k)s
7
FEI Numbers
0
Registration Numbers
0
Unique Applicants
7
Years Active
19
Basic Information
- Product Code
- FIR
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961137 | ATI PLASMA PUMP (PP-04) | Jun 14, 1996 | Substantially Equivalent | APHERESIS TECHNOLOGIES, INC. |
| K831953 | INFUSION PUMP | Jul 19, 1983 | Substantially Equivalent | CRYOSAN, INC. |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Apr 12, 1983 | Substantially Equivalent | PARKER HANNIFIN CORP. |
| K821139 | SPS-SINGLE PATIENT SYSTEM | May 10, 1982 | Substantially Equivalent | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
| K780410 | BLOOD PUMP-MODE S10K | May 03, 1978 | Substantially Equivalent | 3M HEALTH CARE, SARNS |
| K771705 | RS-7800 MINIPUMP | Oct 04, 1977 | Substantially Equivalent | RENAL SYSTEMS, INC. |
| K761050 | HEPARIN PUMP | Dec 30, 1976 | Substantially Equivalent | DWS, INC. |