Connector, Blood Tubing, Infusion T
The Infusion T Blood Tubing Connector is a T-shaped connector used to join blood tubing sections and allow infusion into the dialysis blood circuit. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKB, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.
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Basic Information
- Product Code
- FKB
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.