Pancretec I.V. Model 5000 Infuser
by Abbott Laboratories 510(k)
Active
510(k) K895867
Overview
The Pancretec I.V. Model 5000 Infuser is an infusion pump device classified under product code FRN and device class 2. It is substantially equivalent to a legally marketed predicate device and was cleared via the traditional 510(k) pathway.
The device is manufactured by Abbott Laboratories and received FDA clearance on June 26, 1990, under K895867. It is intended for general hospital use and is regulated under regulation number 880.5725.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895867 | Date26 Jun 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Pancretec I.V. Model 5000 Infuser used for?
The Pancretec I.V. Model 5000 Infuser is an infusion pump intended for general hospital use, as indicated by its product code FRN and medical specialty description of General Hospital, delivering fluids or medications intravenously in clinical settings.
How is the Pancretec I.V. Model 5000 Infuser supplied and is it reusable?
The device is supplied as a reusable infusion pump system; it is not marked as single-use and is designed for repeated use in hospital environments following proper cleaning and maintenance procedures per manufacturer guidelines.
What regulatory pathway was used for the Pancretec I.V. Model 5000 Infuser?
The Pancretec I.V. Model 5000 Infuser received FDA clearance through the traditional 510(k) pathway under K895867, demonstrating substantial equivalence to a legally marketed predicate device, as stated in its decision description and clearance type.