TRI-FLOW THREE WAY STOPCOCK
Device Facts
| Record ID | K961982 |
|---|---|
| Device Name | TRI-FLOW THREE WAY STOPCOCK |
| Applicant | North, Inc. |
| Product Code | FMG · General Hospital |
| Decision Date | Feb 21, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Intended Use
The Tri-Flow™ 3-Way Stopcock is designed to be used in any medical procedure where controlled flow of fluid is required. It is specifically designed to be used in procedures where three different fluids are administered into one line.
Device Story
Disposable 3-way stopcock; used in clinical settings for controlled fluid administration. Device consists of injection-molded body, stem/handle, and swivel nut. Operates by rotating stem/handle to align internal passageways, creating fluid path between male luer port and one of three female luer ports. 'ON' indicator on handle identifies active ports. Used by clinicians to manage multi-fluid delivery into single line. Simple mechanical design; no electronic components or software.
Clinical Evidence
Bench testing only; no clinical data.
Technological Characteristics
Disposable 3-way stopcock; injection-molded body, stem/handle, and swivel nut. Medical grade fluid lubricant used at stem/body interface. Four-channel body design with three female luer ports and one male luer port. Mechanical rotation of stem/handle controls fluid path. No energy source, software, or connectivity.
Indications for Use
Indicated for use in medical procedures requiring controlled fluid flow, specifically for the administration of three different fluids into a single line.
Regulatory Classification
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Predicate Devices
- Medex, Inc. 3-Way stopcock
- North American Instrument Corporation stopcock
- Tronomed/Mallinckrodt stopcock
Related Devices
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- K223499 — Three Way Stop Cock · M/S Romsons International · Jul 21, 2023
- K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L · Nipro Medical Corp. · Sep 21, 2004
- K201741 — Gabriel 3 Way EnFit Valve · Syncro Medical Innovations, Inc. · Nov 5, 2020
- K190489 — Elcam Stopcocks and Manifolds · Elcam Medical Acal · Apr 23, 2019
