Big Bag 3000 Pressure Infusor
by Byron Medical 510(k)
Active
510(k) K973133
Overview
The Big Bag 3000 Pressure Infusor is an infusion pump designed for general surgical fluid irrigation and infiltration. It functions by utilizing compressed nonflammable gases within a closed, inflatable bladder to apply external pressure to a fluid bag.
This device is regulated under FDA 510(k) clearance. It is intended for use in a general hospital setting.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK973133 | Date12 Sep 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- ST