Terufusion Three Way Stopcock
FDA 510(k) K891234 · Terumo Medical Corp.
510(k) numberK891234
Submission
- Device name
- Terufusion Three Way Stopcock
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- March 7, 1989
- Decision date
- September 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Terufusion Three Way Stopcock cleared by the FDA?
Terufusion Three Way Stopcock (K891234) received a 510(k) decision of Substantially Equivalent on September 19, 1989, 196 days after the submission was received.
What is the product code of K891234?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.