Product code FKB— Gastroenterology, Urology
DC-4 SHUNT INFUSION T
- Classification name
- Connector, Blood Tubing, Infusion T
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FKB
FDA has cleared devices under product code FKB between 1977 and 1989, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1989
- 1977
Top applicants under product code FKB
Recent clearances under product code FKB
Data sourced from openFDA. This site is unofficial and independent of the FDA.