Miniloop Dispos. IV Connectors Adapt.
FDA 510(k) K830178 · Medex, Inc.
510(k) numberK830178
Submission
- Device name
- Miniloop Dispos. IV Connectors Adapt.
- Applicant
- Medex, Inc.
Mchenry, IL, US - Received
- January 18, 1983
- Decision date
- February 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Miniloop Dispos. IV Connectors Adapt. cleared by the FDA?
Miniloop Dispos. IV Connectors Adapt. (K830178) received a 510(k) decision of Substantially Equivalent on February 7, 1983, 20 days after the submission was received.
What is the product code of K830178?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.