Pump, Infusion Or Syringe, Extra-Luminal
The Extra-Luminal Infusion or Syringe Pump is a pump device used in conjunction with hemodialysis equipment to infuse anticoagulants, saline, or other fluids into the extracorporeal circuit. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIH, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
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Basic Information
- Product Code
- FIH
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932055 | PERCUPUMP II | Mar 21, 1995 | Substantially Equivalent | E-Z-Em, Inc. |
| K935461 | VECTOR AMBULATORY DRUG DELIVERY SYSTEM | Apr 28, 1994 | Substantially Equivalent | Infusion Technology Intl. |
| K931113 | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | Apr 28, 1994 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | Feb 15, 1990 | Substantially Equivalent | L H M Ent., Inc. |
| K881707 | INTROCULAR FLUID INJECTOR | Oct 21, 1988 | Substantially Equivalent | B&B Medical Assoc., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.