Venoset Multi Med Dual Rate Piggyback
by Abbott Laboratories 510(k)
Active
510(k) K833741
Overview
The Venoset Multi Med Dual Rate Piggyback is an administration set for intravascular medical use. It is designed for dual rate administration of medications intravenously.
This device is supplied by Abbott Laboratories and received FDA 510(k) clearance with number K833741 on December 22, 1983. It is classified as a Class II device under product code FPA for general hospital use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833741 | Date22 Dec 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0957-03
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Venoset Multi Med Dual Rate Piggyback used for?
The Venoset Multi Med Dual Rate Piggyback is an administration set designed for intravascular medical use, specifically for dual rate administration of medications intravenously. It allows for controlled delivery of multiple medications through a single IV line.
How is the Venoset Multi Med Dual Rate Piggyback supplied?
This device is supplied by Abbott Laboratories. It is classified as a Class II device under product code FPA for general hospital use, indicating it's designed for standard medical environments where healthcare professionals can safely administer dual-rate IV medications.
What is the regulatory status of the Venoset Multi Med Dual Rate Piggyback?
The Venoset Multi Med Dual Rate Piggyback received FDA 510(k) clearance with number K833741 on December 22, 1983. It was determined to be substantially equivalent to other legally marketed devices, allowing it to be distributed for general hospital use under the FDA's regulatory framework.
Is the Venoset Multi Med Dual Rate Piggyback single-use or reusable?
The device data does not specify whether the Venoset Multi Med Dual Rate Piggyback is single-use or reusable. As an intravascular administration set, it would typically be considered a single-use device to prevent cross-contamination and ensure patient safety, but this should be confirmed with the manufacturer's current instructions for use.